The intern will work in the global Packaging Development group, supporting the Distribution Technology team by characterizing the mechanical properties of different materials used for packaging in the Roche network. The intern will also be using the information gathered in the laboratory to model those materials in silico, and to identify attributes critical to performance. This will help the Packaging Development group by optimizing the final package design proposed while accelerating development and qualification activities. A final report and presentation are expected at the end of the internship.

The intern will learn how to use multiple test equipment including but not limited to Universal (push and pull) test machines, compression, shock, drop and vibration machines, as well as measurement devices. The intern will also learn how to use software for documenting laboratory results, 3D modeling software and effect modeling software. Finally, the intern will get the opportunity to learn about and support other projects in Packaging Development.

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

Global Regulatory Leader

Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.

Primary Responsibilities and Accountabilities

• Accountable for global regulatory strategy and global regulatory deliverables for a PD project 
• Accountable for leading a matrix team of Regulatory Professionals, and for the RAFT deliverables.  Responsible for motivating and inspiring RAFT members
• Responsible for holding regular RAFT meetings, in accordance with RAFT guidance.
• Responsible for representing the regulatory function on cross-functional project teams (Lifecycle Teams).
• Responsible for representing the regulatory function on project specific matters to governance bodies
• Accountable for global regulatory Health Authority Interactions
• Accountable for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team and RAFT.  Responsible for ensuring appropriate escalation to functional management when necessary.
• Accountable for leading the RAFT on a PD project to:

• deliver strategic regulatory input to the lifecycle management of a project. 
• deliver specific guidance on regulatory issues such as legislation, guidelines, procedures to internal stakeholders (project team, regulatory function, governance bodies) 
• deliver integrated plans relating to regulatory submissions or specific functional projects 
• deliver regulatory submissions, in accordance with project timelines
• manage successful interactions with regulatory agencies and 
• analyse and landscape the regulatory environment for impact on the project and to brief internal stakeholders, as appropriate
• Responsible for sharing best practices within function to ensure efficiency and consistency across teams.
• Responsible for leading special regulatory projects/global process initiatives, as assigned.
• Responsible for acting as a change agent and role model within PDR by modeling best practices.

Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more clinical operations teams
• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
• Creates team culture and promotes team spirit.
• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
• Oversees the development and maintenance of study specific manuals created by the GSA.
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 
• Provides operational input into the development of protocol feasibility questionnaires. 
• Provides clinical operations expertise to ensure operational feasibility and delivery
• Leads the development and finalization of site feasibility questionnaires.
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
• Oversees forecasting of clinical/non-clinical supplies
• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
• Delivers the operational elements of the study plan
• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
• Ensures that reporting of SUSARs is established and maintained for the duration of the study.
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
• Provides operational input into the development and tracking of SMT goals.
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Develops and executes appropriate site and CRO/vendor audit and quality plans.
• Identifies areas of best practice and process improvements
• Participates in Pharma Development Operations initiatives and programs as assigned.
• Maintains oversight and ensures consistency of the operational aspects across studies within a project.
• Ensures study adherence to ICH/GCP and SOPs
  

A Senior Scientist/Associate Director position is available for a highly motivated and innovative scientist with strong leadership and collaborative skills to join our antibody drug conjugation (ADC) program.  Candidates should have extensive experience in protein and antibody conjugations and be a demonstrated thought leader in the ADC field so that they will be able to make immediate contributions to a vibrant and productive program undergoing expansion at this time. The successful candidate will interface with both chemist and biologist in developing new technologies for the production of ADCs as well as optimizing current strategies. The position allows the successful candidate to play a pivotal role in augmenting Genentech’s strong clinical pipeline of new therapeutic ADC candidates.

Group Product Manager, Erivedge Key Customer Team

The Group Product Manager (GPM) will report to the Erivedge Marketing Director. This position offers the opportunity to lead the brand analytics, access initiatives and key customer relationships for Erivedge, a first-in-class hedgehog pathway inhibitor indicated for the treatment of advanced basal cell carcinoma (aBCC). The role will be accountable for tracking performance indicators, implementation of access-to-care and practice management tactics and thought leader engagement, while leading a team of two marketers. Specific responsibilities include development of quarterly business reviews, thought leader development, advisory activities, peer-to-peer promotions, managed care / access programs and providing appropriate commercial perspective to publication planning and medical teams.

Additional responsibilities of this position include: 

• Collaborate with MCCO to ensure understanding and execution of brand strategies within appropriate payer and field-based tactics
• Lead initiatives with MCCO to optimize patient flow from script to shipment 

• Manage development and implementation of thought leader strategies including major conference activities, internal management tools, and participation/involvement in key promotional activities
• Collaborate with field sales, TLLs, marketing colleagues on thought leader activities
• Collaborate with BioOncology partners for implementation of major meeting activities

• Collaborate with Medical Affairs, Clinical Science, and Advisory Board Services to manager advisor activities
• Lead data integration team toward developing and tracking key performance metrics in collaboration with market planning, marketing science, sales operations and forecasting/business analytics team
• Lead and motivate team of two direct reports and manage all activities and professional development
• Managing brand budgets 
• Maintain strong relationships with colleagues in research, clinical, medical affairs
• Actively participate in Oral Oncolytics and BioOncology initiatives and programs
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Successful candidate should possess:

- Solid understanding of specialty biotech/pharmaceutical marketing and sales

- Solid experience with proven results in managing and motivating direct reports in a marketing role 

- Strong analytical and communication skills

- Direct experience managing through leader relationships and/or extensive knowledge access dynamics for part D drugs

- Proven ability to develop relationships with sales force and across departments for support of strategies 

- Proven ability to work in a fast-paced, collaborative environment which requires significant cross-functional and cross-brand coordination and teamwork

- Proven ability to work in teams and also work autonomously 

- Experience in working with commercial promotional review committees

- Proven track record of adhering to timelines and budgets

Group Strategy Manager 

 
The  purpose of the Group Manager, Strategic Pricing & Contracting role is to oversee and/or develop pricing and contract strategies for the assigned therapeutic areas and/or customer segments that optimize the value of Genentech's portfolio, which includes leading cross-functional strategy development teams, building effective relationships across all franchises relevant to the assigned therapeutic areas and/or customer segments and scenario analysis/modeling for overall financial and legal viability, as well as ongoing pricing and contract performance assessment/analysis.

1. Act as a lead subject matter expert from Strategic Pricing & Contracting
2. Play the lead role in cross-franchise assessment and integration of pricing and contracting strategies, plans and tactics; includes providing a leadership perspective and strategic pricing and contracting inputs into all business plans relevant to the assigned therapeutic areas and/or customer segments
3. Provide a leadership perspective on Genentech pipeline developments, as these relate to pricing and contracting strategies development and strategic options
4. Work effectively with Genentech executives to transfer and leverage learning across brands
5. Act as the lead contact on all internal and external communication regarding pricing and contracting strategies, philosophies and practices for the assigned therapeutic areas and/or customer segments; includes responding to internal/external inquiries regarding Genentech's pricing and contracting philosophies and practices
6. Develop internal/external reports, presentations and training to educate others in Genentech's pricing and contracting philosophies and practices
7. Take a leadership role in training other team members and internal partners/stakeholders in pricing and negotiating theory/application
8. Support manager in longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools and the like
9. Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies

• 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

Purpose:

Accountable for the deployment andrealization of the Quality and Compliance strategy for PharmaGlobal Technical Operations (PT) External Quality Operations CMO - Biologics.

• Directaccountability for Quality and Complianceactivities and organization across PT’s external CMOsfor Biologics
• Leadingdeployment and full realization of the PT QualitySystem requirements through Quality Agreements and Contract  Quality Requirements  with externalCMOs.
• Ensurean objective, proactive cGMPcompliance program is established andoperational.
• Qualityresponsibility for extention ofmanufacturing network into EM (India, Russia, Brazil) and forDevices
• Product qualitymanagement activities
• End-to-end externalCMO - wide Quality Risk management
• Directcontinuous improvement activities ofexternal CMOs toimprove Quality and Compliance performance.
• Sponsor forthe Global Quality external CMO issues management process and system.
• Directlyresponsible for External Quality Operations CMO organization
• Overall budgetand financial performance for External Quality Operations CMO organization.
• Accountablefor demonstrating and realizing Roche’score values and expected behaviors.

• Lead and manage the global PTD Planning  group. This includes establishing a vision and mission for the group and the global PTD planning network with clear roles and responsibilities for local and global activities, establishing and maintaining PTD planning business processes and planning operations in strong partnership with the PTD functional planners, and conduct regular alignment meeting with the PTD planner community ensuring resource allocation transparency, PTD finance, TDLs and TDT PMs, yearly maintenance of generic plans in Plansource with eRAM update, establishing training for planning functions and groups within PTD, resource planning data analysis and scenario planning to support PTD strategy initiatives. Supports budget cycle from the PlanSource perspective
• Accountable for projects and portfolio reports and portfolio analysis. This includes maintenance of reports, creation and/or retirement, and distribution of reports to meet the business needs of PTD and its stakeholders. Creates strong partnership with Global Portfolio Management aligning the PTD reporting with Corporate portfolio.
• Represents PTD on PlanSource Steering group and drives for PlanSource operational processes updates and change management within PTD.
• As a member of the PTDM leadership team, works collaboratively to establish priorities and directions for PTDM globally. Contributes to the development of department business initiatives and facilitates their implementation.
• Fosters a culture of high performance, trust and collaboration across all PTD planning stakeholders. Builds and cultivates a strong network among PTD functional planners, Finance groups, PlanSource expert groups, TDLs and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.  Helps to surface, analyze and resolve planning related issues and resource conflicts.
• Recruits, retains and develops talent. Establishes and implements training and development plans as required, providing constructive feedback as well. Supports the creation, use and continuous improvement of standard planning systems, tools and processes. Interacts closely with TR&D functional leaders and key stakeholders within the Research and Early Development, Development and Technical Operations organizations.

Purpose:

The Head of Small Molecules Development Products, North America, in External Quality is accountable for the development and deployment of the Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the gRED Small Molecules development portfolio. Accountable for all aspects of Quality related to these CMOs to include: Quality Systems, Product Quality Operations, Process Qualification and Validation, cGMP Compliance, Risk Management, GMP Audit and Inspection Readiness. Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche’s reputation as a reliable, high quality supplier of IMP products. In collaboration with other PTx and gRED functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements. Responsible for risk management utilizing risk management tools for each CMO within group’s scope. Accountable for the management of Quality and Compliance within the group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Responsibilities: 

* Management of the North America Small Molecule Development Products Group

* Staff and assign Quality Managers to lead quality teams for IMP products after approval to proceed to development utilizing CMO manufacture 

* Lead Quality Managers in the implementation and execution of Quality processes for the selection, implementation, and ongoing management of development CMOs

* Accountable for the Quality and Compliance Status for all CMOs within the group’s scope of operations 

* Establish and manage performance metrics for the Key Performance Indicators (KPI) 

* Determine staffing requirements and provide input to department budget

* Establish individual goals for direct reports, provide performance management for direct reports, and conduct talent management in accordance with Roche standards and procedures

* Accountable for the deployment of the Roche PT Pharmaceutical Quality System (PQS) standards and requirements for outsourcing for all Small Molecule Development CMOs used for the gRED portfolio, ensuring appropriate risk assessment and mitigation for identified gaps

* Participate in Joint Steering Committees through the established Governance processes as required. Define quality actions to be resolved and/or escalated to Roche senior management at the Executive Steering Committees.

* Accountable for approval of:

* Quality Agreements Appendices, such as PSRs, for Development CMOs on behalf of Roche Quality

* IND and IMPD Manager Level reviews

* Major Deviations or Changes in Roche Approval systems

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 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 

Job Purpose:

The IT Business Systems Analyst (BSA) position in the Patient & Physician Solutions team will be responsible for the delivery of technology capabilities for the Access Solutions organization in the US, which provides services to help people access Genentech medicines for a range serious conditions. The IT BSA will work on multiple projects for both internally-facing case management tools and externally facing web-based solutions serving physicians and patients, and will be accountable for understanding the needs of customers, developing effective user-friendly designs to meet those needs, and delivering detailed requirements and specifications to drive the development, testing, deployment and production support of IT systems.  

Primary Responsibilities:

The IT Business System Analyst (BSA) will drive the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path.   The IT BSA will assist in determining which methodology path will be most likely to ensure a successful delivery.  The BSA will be responsible for building deep understanding of processes used by medical practices and internal case managers to serve patients, and for integrating the knowledge into the design and delivery of tools to serve all users.  The IT BSA will establish themselves as a “thought partner” with internal customers.   The IT BSA will assure smooth integration with key partners leading the development, testing, training, communication and deployment of technology across the country, keeping management apprised of developments through clear and timely communication.  

Specific responsibilities include: 

• Collaborate with Project Managers, Architects, Engineers, Developers, User Experience Designers and Software Quality Assurance on scope, solutions, constraints, and risks 
• Analyze/document current and future business process models 
• Analyze/document high-level requirements (scope) 
• Analyze/document detailed functional requirements and business rules (use cases) 
• Analyze/document data requirements (from business needs perspective) 
• Support planning of user acceptance test (UAT), including creation of UAT scripts 
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed
• Lead business stakeholders and other business systems analysts thru the business analysis lifecycle

The Position

The IT Project Management position in the Patient & Physician Solutions team will be responsible for leading the delivery of technology projects in support of the Access Solutions in the US, which provides services to help people get access to Genentech medicines for a range of serious conditions.  The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path. The IT Project Manager will be responsible for supervising work by the assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The IT Project Manager will be accountable for projects in the Patient and Physician portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers.

Primary Responsibilities:

• Define, plan, and direct the execution of technical projects, balancing the competing demands of scope, time, cost, quality, resources, and risk
• Identify, acquire, and lead multifunctional project teams
• Manage multiple projects, in addition to individual projects assigned to the position
• Ensure project objectives/requirements are clear and agreed to by all stakeholders
• Manage relationships with various technology and business communities to achieve project objectives
• Facilitate project management activities across the entire project management methodology
• Establishes and maintains effective communication for assigned projects and with dependent projects
• Ensure successful and timely completion of deliverables
• Track progress against baseline schedule
• Plan, baseline and control costs to ensure projects are completed within approved budget
• Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet relevant Computer System Validation directives
• Suggest improvements where necessary / appropriate to improve operational efficiencies
• Conduct risk management planning, identification, analysis and monitoring on projects
• Formulate risk mitigation strategies and recommend solutions
• Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems
• Assign and supervise project activities to the team leads and team members.  Communicate and coordinate assignment and resource-related issues to Genentech management and resource vendor representatives.
• Other duties as assigned