We are seeking a collaborative individual to contribute to a team that is responsible for generating recombinant proteins by transient transfection of mammalian cells. The candidate’s primary responsibility will be high throughput transient protein production to support research and development projects. The tasks will include those associated with coordinating and performing cell culture operations (i.e. set up, inoculate, monitor, harvest and clean fermentors) as well as experiment data recording, collection and analysis. He /she will display a strong focus on collaboration, attention to detail, proficiency with multi-tasking and analytical ability. The secondary responsibility of this candidate is to optimize our transient transfection process. This includes identifying and solving technical issues, performing process development experiments, and evaluating and implementing new technology/instrumentation based on scientific literature and industry trends.  The right candidate will have experience with supervisory or management responsibilities.

The Scientist will be a member of the Protein Analytical Chemistry Validation Department (PAC-V). PAC-V is one of the seven departments that comprise Analytical Development and Quality Control  (ADQC) organization within Process Research and Development.

PAC-V  is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system. PAC-V is responsible for both the development and execution of the strategies. The candidate will provide practical guidance and expertise to ensure the appropriate and timely progression of acceptable validation activities across the Protein Analytical Chemistry Department.

The candidate must have in depth scientific knowledge and hands-on experience in the development, robustness testing, and validation of analytical methods, covering a wide array of analytical techniques such as HPLC, CE, MS, and wet-chemistry. He or she will be involved to ensure the proper and timely execution of all aspects of the life cycle clinical analytical methods across Genentech's clinical product portfolio and testing sites (including CMOs and partners).

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for QC testing. The candidate is also expected to represent PAC-V in cross functional teams. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.

Job Description:

A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of high throughput experiments and lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in microbiological challenge studies (i.e. disinfectant efficacy testing, antimicrobial effectiveness), sterility testing method and isolator validation, as well as deviation assessment/management.

Main Purpose of the Position:   
• Develop solutions to complex Quality Control testing activities and issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Perform Quality Control testing for product release and stability samples.
• Support quality investigations for testing and test method discrepancies.
• Perform equipment validation for laboratory instruments used in cGMP testing activities.
• Provide input into the generation of stability study protocols.
• Collaborate with departments to ensure product release and stability testing requirements are completed.
• Communicate testing or scheduling issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation and testing activities.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

Support the implementation of Internal Customer Relationship Management process. Leverage knowledge from within PTQS to analyze customer interactions and develop a model for managing interactions between Computer Systems Quality and Informatics.

Currently Informatics performs many activities which we rely upon to ensure the Right-To-Operate. Some of these activities directly support documented requirements for compliance while others do so less directly. Activities vary with complexity and so do the means and ways we interact with each other. Increased variability due to complexity results in less than optimal outcomes. A model for more predictable collaboration, interaction, and participation will improve efficiency, alignment, and customer relationships. An analysis of customer groups and interactions will need to be performed and conveyed via diagrams/charts. The diagrams and or charts will be used to understand the relationships in order to build a governance model for interactions. The governance model will need to minimally include a common understanding of agreed upon customer relationship, basic, concise overarching needs or expectations, and the foundation for: timely communication, appropriate involvement, proper engagement, performance measurement via tool, and decision making pathways.

Key stakeholders will need to be identified. The governance model will be built with customer collaboration. As intern you will be responsible for coordination and scheduling of activities pertaining to the delivery of a governance model, customer relationship mapping/diagrams/charts, and a performance Indicator tool. This means one of the first items after orientation will be to understand the project and then start working on a timeline with actions and planned dates. Your responsibilities will also include gathering knowledge from PTQS SME experts in order to understand best methods for mapping customer relationships. Working together with PTQS and customer to complete the mapping/diagrams/charts. You will need to research performance tools available inside the company and externally and are responsible for providing a list of optional tools and a comparison of benefits for each tool based on the expected use. As intern you will draft a governance model framework as defined by the sponsor, which will subsequently be collaboratively detailed by the customers. You will be responsible for communication and follow up actions with stakeholders.

Strong communication, presentation and organizational skills are necessary.

Intern Project Deliverables

Customer Relationship Management (CRM) governance model
Customer relationship mapping/diagrams/charts
Performance Indicator tool
Presentation of the project which illustrates the work performed, deliverables completed, and value provided

Solution Architect – Regulatory

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

The Position

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

• Works with others to assess existing learning & development curricula and specific programs and other offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; providing detailed partner/stakeholder input that helps shape the direction, specific offerings, as well as content and facilitation methods/structure for ultimate design and facilitation alignment
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, programs or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development plans, programs, and activities
• Translates annual or other cycle learning & development plans, programs & activities into a scheduled calendar of specific sessions/dates for facilitation. Supports manager, peers, team members and others however necessary to finalize and disseminate such calendars, as well as respond to any internal client or external partner questions, concerns, or other comments
• As and when requested, supports others in the development and implementation of an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate department's offerings and support strategies
• Actively pursues continued education and awareness of field, product, disease state(s)/indication(s) and surrounding marketplace changes/developments, and uses where appropriate to incorporate into program and other learning event/activity facilitation, as well as provide such information to manager and team members for continuous departmental review/assessment of existing learning & development offerings
• Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
• Uses approved learning & development plans, curricula, schedule/calendar, specific programs and activities for assigned responsibilities to proactively learn program/other activity content and prepare for expert facilitation. Channels questions, other needs or challenges - in advance - to the appropriate partners; further ensuring full and exacting preparation for expert delivery of assigned learning/development content
• As approved, conducts regular field visits, working with field staff and management one-on-one or in teams. Provides field consultation, team and/or individual coaching and development; enabling hands-on learning/development support to the assigned employee/management groups
• Continuously assesses and evaluates impact and overall effectiveness of facilitation responsibilities. Does so by consistently reviewing learning program participant evaluations, as well as soliciting additional or other feedback, extracting key themes, patterns and opportunities and channeling such to the appropriate internal partners or stakeholders
• Works with peers/team members to ensure maximum leverage of existing resources, tools, programs, content, etc.
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

• Assesses existing learning & development curricula and offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May develop, manage or individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; enabling self, team, department and overall function with detailed partner/stakeholder input
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, specific programs and/or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development support
• Works with others to develop and implement an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate team's offerings and support strategies
• Works with others to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or other
• Works with manager and peers, and oversees team in such a way as to, continuously assess and evaluate learning & development plans and activities to ensure continuous, strategic alignment to meet or exceed internal business partner and other stakeholder needs and objectives
• Consistently monitors and supports team's work and associated work output. Regularly coaches, advises and gives further direction to help team members fine-tune and hone their work to meet or exceed assigned goals and objectives
• Ensures self and team members, where and when appropriate, seek regular internal client or other partner/stakeholder input into in-development work; does so to ensure maximum alignment to internal client needs, objectives and goals
• Consistently oversees the execution/implementation of team's work to ensure timely and best quality output. Manages similarly with any applicable external partners; ensuring their work is on-time, on-target and within-budget to meet or exceed assigned goals, objectives and other expectations
• Hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Oral Octreotide Brand Trainer
*Position is based in SSF headquarters

The Brand Trainer supports specific brands in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands product(s) in addition to be able to create training programs for both new hires and advanced sales representatives.

Major Responsibilities:

• Determines the most effective approach to meet product-learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develops Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics that will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Advanced (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals.
• Participates as an active member on Commercial and Brand product teams
• Facilitates “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

The role of the Validation Engineer, located in San Francisco, is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual to  work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. 

The selected candidate will be responsible to:

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).  This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.

Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.  

Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment

Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units  to identify best practices,  and lead improvement initiatives across functional areas

Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics

Provide change request control and support for legacy GMP systems 

Level: E4/E5
The position is for a recognized expert and leader as it relates to process and cleaning validation and operations with the ability to gain alignment, advise, coach and train.  This includes expertise in the principles and approaches of process and cleaning validation, and is responsible for leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements.  The Principal Technical Manager will develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Recognized expert and leader as it relates to process and cleaning validation and must have the ability to gain alignment, advise, coach and train Validation and Operations personnel with respect to process and cleaning validation requirements.
• Expertise in the principles and approaches of process and cleaning validation, leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements. 
• Develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Identify and implement solutions to complex Quality system governance concerns and improvement opportunities with multi-site and inter-organizational impact. 

Key Accountabilities:
• Provide Process and Cleaning Validation and Operations expertise to develop, implement, and sustain PQS requirements in accordance with worldwide GMP regulations and Roche standards.
• Act as Global Coordinator for the development, deployment and implementation of the  PQS Product and Process Lifecycle and associated global standards and processes.
• Adhere to Roche’s Quality philosophy and utilize PQS business process and applicable Quality systems, i.e., CAPA and Technical Change Management tools.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Who You Are:
• Collaborative Leadership – Looks for opportunities to help others.  Works well in a collaborative team environment and communicate effectively with customers, peers, and senior management.  Demonstrates respect and appreciation for a diversity of perspectives.  Maintains professionalism in presence of conflict.
• Technical Leadership – Demonstrates ability to provide technical leadership and teamwork in a GxP environment across functional and organizational boundaries.
• Ownership and Accountability – Takes accountability for actions, drives results, and learns from mistakes.  Holds oneself accountable to fulfill assigned tasks and achieve results within timelines.  Initiates additional assignments and assumes responsibilities as appropriate.  Determines methods and procedures on new assignments.
• Communication – Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing.  Readily grasps the main points in communication from others.  Asks questions for clarification.
• Planning/Organization – Responds to new requests with appropriate urgency and with an organized approach.
• Problem Solving – Identifies problems, defines problem statement clearly and accurately, and applies structured and disciplined methodology to identify root causes.  Is effective in solution development, risk mitigation, stakeholder buy-in, and execution.
• Customer Focused – Partners with customers and looks ahead to predict future customer needs.  Manages expectations.
• Technology Platform Experience – Has exposure to and expertise in multiple GxP environments.  Executes work in collaboration with multiple technical disciplines.

Accountable for developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of the Pharmaceutical Quality system.  Accountable for planning, leading and coordinating activities involved in the implementation, governance, and continual improvement of the Pharmaceutical Technical Operations (PT) Quality Risk Management (QRM) Program including standards, business processes, and tools within the Pharmaceutical Quality System (PQS) to ensure consistent and GMP compliant QRM practices.  Engage in external interactions to influence the development of industry best practices in a manner that provides a competitive and strategic advantage to Roche; monitor the external environment for regulatory changes and emerging issues. 

Lead Knowledge Management and Quality Risk Management function including organizational design and implementation, staffing, talent management, performance management, financial budgeting and financial performance, and execution to meet strategic and operational goal.  Specific focus on developing organizational model to support PQS Knowledge Management program. Direct staff in setting operational objectives and business goals for their respective areas of responsibility. Establish and monitor performance measures and objectives for the function.

Major Responsibilities
• Accountable for the development, deployment, full realization, and continual improvement of the PQS Knowledge Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Includes developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of ICH Q10. Specifically includes implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools.

• Accountable for ensuring that the PQS Knowledge Management program is integrated with other PT knowledge management and business intelligence initiatives.  Influence across matrix to drive strategic approach and decisions at a functional and cross-functional levels.

• Accountable for the development, deployment, full realization, and continual improvement of the PT Quality Risk Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Specifically includes the following: implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools

• Accountable for ensuring integration of QRM throughout the product and process lifecycle, and as an enabler within the Pharmaceutical Quality System (PQS).

• Responsible for proactive identification, assessment and management of Quality and Compliance risk across PT operation to ensure compliance and quality supply to patients.

• Accountable for partnering with customers, key stakeholders and senior management across PT Global Operational Units, Functional Units and sites to a.) communicate and escalate Quality risks, resolve conflicts, and drive value-add risk based processes, pragmatic decisions and practices and b.) ensure the Knowledge Management Program for PQS is appropriately integrated with other knowledge management and business intelligence initiatives across the PT organization.

• Serve as Quality representative to the Integrated Risk Management (IRM) Core Team.  Accountable to work in conjunction with the IRM team to implement, maintain, and continually improve the RM Training and Certification Program.  Ensure all roles involved in QRM activities across all levels of the organization are supported through the RM training and certification program.

• Accountable for implementation, sustainment, and continual improvement of processes that ensure proactive identification and management of Quality and Compliance related risks across PT operations to ensure compliance and quality supply to patients.

• Communicate regularly with appropriate management and decision makers to ensure potential quality or regulatory issues that may affect product quality, patient safety or regulatory compliance are escalated and managed adequately.

• Implement, maintain, and communicate relevant QRM metrics.

• Actively engage in external interactions (including regulatory agencies) to influence the development of industry best practices for QRM in a manner that provides a competitive and strategic advantage to Roche.  Support staff development through targeted participating in industry activities.  Monitor environment...

The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

The PD/PT Regulatory Affairs Informatics (FPPR) team is looking for a highly skilled Delivery Service Manager, who will support the Submission Management systems area.  This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills.

Further responsibilities are:

• Applies complex procedures and defined standards to meet current business, customer and technical requirements and leads others in resolution of complex problems.
• Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.
• Develops business/technical critical know-how within area of expertise for the function and is familiar with opinion leaders in the field. Assists in the development of others know-how by passing on knowledge of tools and techniques.
• Supports day to day operations and / or implementation of projects within area of technical expertise, contributes to the implementation planning and may execute some aspects of that plan. Accountable for roll-out of new services or enhancement to existing services.
• Manages incident and problem management processes, release and configuration management according to ITIL. This includes continuous improvement for the management of the services. Acts as the initial point of escalation for incident, problem and change management for the Business Representative (e.g. Business Lead)
• Administers change control procedure and processes. This includes the management of the change control board and oversight of the approved change
• Is well-versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships.
• Is familiar with Statement of Work (SOW) and procurement processes
• Is customer-focused and able to track problems/issues to their resolution with the appropriate level of follow-up to the user community
• Builds and maintains good working relationships with the Business Representative and the client business base , monitors services and providing regular service reports to the FPPR management and business clients

Location: San Francisco

Research, Facilities, and Procurement Services

Primary Purpose of Job (Job Summary)

The Category/Souring Manager, Facilities Procurement is to provide strategic leadership to the Facilities Procurement organization in support of Global Categories related to Facility Operations and Services.  This position is responsible for: establishing full strategic planning (Regionally and interfacing Globally) on behalf of the Facilities Procurement function in alignment with the Pharma Business and Corporate goals and objectives; identifying and introducing best practices in the Facility Procurement processes; acting as a change agent who supports and influences the business in an effort to create value and efficiencies across the Global and NA Regional networks; focusing on return on investment benefits, Category Lifecycle Management and Total Cost of Ownership; evaluating savings opportunities in partnership with key business partners and stakeholders and maximizing the value of third-party services across a portfolio of sub-categories.  The Global/Regional Category Manager will lead cross functional teams through strategic category sourcing to deliver breakthrough business benefits.

Functional Roles & Responsibilities

The Global/Regional Category Manager, Facilities Procurement will have a Category Strategic and Supplier Management focus of assigned Global/Regional Categories related to Facility Operations and Services.  This position leverages category management expertise to manage the purchases of goods and services, with the aim of achieving optimal total cost of ownership.  This position provides end-to-end strategic solutions, from idea generation through to presentation to senior business management and initiative execution and will fully utilize the eSourcing tools including eAuctions when appropriate to drive the costs down and out across the assigned categories.

Responsibilities:

* Develop strong working relationships with internal teams, key business partners and leaders throughout the Global and Regional organizations/networks.  

* Partner with global colleagues to develop and implement the global category management roadmap.

* Build and maintain excellent relationships with key affiliates, Roche group companies, and global functions so that Roche collectively benefits (e.g. global savings, service delivery, vendor selection, etc.).

* Partnering with stakeholders and business partners to identify and support sourcing projects that reduce risk, timeline, stakeholder pain-points or cost and add value without sacrificing quality or effectiveness.

* Lead and/or partner with various multifunctional teams on strategic initiatives which also include accountability for implementation planning and tracking of expected outcomes.

* Aligning the priorities, activities, and progress of goals across the Facilities organization, so that high value and quality customer service is delivered.

* Provide Strategic Category and Supplier Management:

o Develop an advanced understanding of category subject matters to include Analyzing Category and Supplier Spend history, trends and forecasts

o Establish and manage robust Supplier Relationship Management programs for Strategic/Key suppliers

o Lead Category activities and Sourcing Managers in the development and execution of the spend category sourcing strategies for key initiatives.

o Develop detailed supplier knowledge, market data, including financial performance (P&L, balance sheet, debt structures, trends, history, executives, ownership, parent companies, size, concentration of sales to GNE, diversity of sales volume)

o Analyze past and future demand volumes, inventory trends and current inventory levels

o Document supply-chain for key goods and services

o Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Lead sourcing projects including sourcing strategy development, market analysis, and supplier negotiations, and supplier relationship management

o Monitor Strategic/key Suppliers (earnings, SEC filings, RSS feeds, Alerts) to provide internal notifications to key stakeholders that includes developing risk mitigation scenarios

o Ensure Diversity Suppliers are included in sourcing events

o Know, understand and stay abreast of industry trends, benchmarks, best practices, etc.  Develop and implement a strategy to gain competitive advantage.

* Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations.

* Demonstrate advanced industry knowledge and facilitation skills so that this role leads the negotiations of contractual requirements that includes managing complex RFP/RFIs, making sele...