Provide automation support for biopharmaceutical manufacturing operations as part of the Vacaville Technology Upstream Frontline Group. Support will primarily be focused on the manufacturing production Distribution Control Systems (DCS) system involving cell culture manufacturing including fermentation, media prep, and harvest operations. Candidate must be a self-starter who can independently drive day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member in an informal results oriented environment.

Responsibilities: Automation design and support to the manufacturing Distributed Control System (Siemens APACS, APS, Archestra) as well as providing support to implement automation changes. This person is expected to perform troubleshooting of process, equipment, and system malfunctions or failures involving the DCS system, including after-hours on-call support on a rotational basis. Ability to initiate corrective or preventative actions to ensure continued compliant operation including emergency change records as needed. Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as provide technical input for investigation and/or developing and implementing corrective action plans. A key part of this person’s role will be to redline automation functional specifications for automation lead review/approval, troubleshoot the DCS system and software, prepare automation software change work plans and perform off-line and on-line coding and testing. This person will support automation projects with activities such as detailed design, design review, implementation, testing/debug, and troubleshooting. This position includes working with the Manufacturing, BSI, Quality, Facilities, and Technology departments to implement software changes. This person will be expected to clearly communicate across functional departments at various levels to drive efficient issue resolution and change implementation. The position may involve the cross-training in another discipline within Upstream Frontline, such as Validation, Process Engineering, or Manufacturing Sciences where business needs allow.

Reportingto the Vice President – SSF  Production, the Director of Technology willbe responsible for manufacturing science, validation, automation, recipe anddocument development and engineering functions in direct support of production.

*Provide support to operations departments in make, assess, release activities;plan and execute process related capital projects within the plant incollaboration with Corporate Engineering; work closely with GlobalManufacturing Sciences and Technology (MSAT), Process R&D, RegulatoryAffairs and Quality, representing the plant on technology transfers, regulatoryagency inspections and other issues and projects; foster innovation intechnologies, processes and systems as part of continuous improvement and cGMPefforts.
* Ensure goals, priorities, budgets and strategic plan are appropriatelyestablished and aligned.
* Ensure proper resources are available (people, materials, equipment,facilities, processes) to meet current and future goals.
* Ensure an uninterrupted supply of product in the near- and long-term.
* Ensure systems are in place to successfully complete regulatory inspections.
* Plan & manage to continuously improve safety, quality, reliability andefficiency.
* Actively promote and lead Continuous Process Improvement (CPI), Root CauseAnalysis (RCA), and risk assessment tools such as FMEA.
* Ensure qualified staff are hired, trained, developed, and recognized.
* Develop, review and approve GMP documentation and regulatory submissions.
* Work in partnership with other Genentech staff to develop and championpolicies, best practices, decisions and strategic plans.
* The incumbent will be responsible for directing, managing, and orchestratingTechnology functions within the South San Francisco Drug Substance and DrugProduct manufacturing facilities utilizing CHO and Bacterial production systems,and liquid and lyo fill lines to make commercial and clinical product.  

Director of Portfolio, Project & Process Excellence 

Location:  San Francisco, CA OR Basel, Switzerland

Purpose

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and has full accountability for driving global prioritization of our GPP portfolio and ensures the effective management of our transformation projects through excellence in project management and efficient processes.

* This leader is responsible for connecting together one GPP project portfolio that includes all GPP projects and ongoing resource management.

* Accountable for the Lean Six Sigma infrastructure by building short and long-term capabilities within GPP to meet the vision of becoming the best procurement team in our industry. 

* Partners closely with stakeholders and customers to collaborate, influence and execute on project and  Business Process Excellence across the entire organization.

Key Relationships

* GPPLT – final portfolio decision maker

* GPP Functional Leaders – functional portfolios feed into GPP portfolio; support BPE projects

* GPP Operations - Support the S2P Business process owners through continuous improvement

* Provide BPE expertise to business partners to support improvement to their processes

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 5 direct reports, with a team of 15-20 employees and contractors.

* Oversight of the GPP Portfolio, Business Process Excellence, Project Management function and dedicated Project Communications support.

* Portfolio:  Prioritizes portfolio projects for GPP globally including resourcing and solution management.  

* Identify and prioritize strategic and operational initiatives to improve GPP’s performance along financial (savings), customer, process and people dimensions. 

* Prioritize the overall GPP IT Solution management and roadmap including maintenance and enhancements.

* Project: Develops a consistent stage gate review process to ensure all projects are set for realization of their intent and sponsorship.

* BPE and Project Support:  Provides vision and guidance to effectively support business process excellence – through achievement, sustainment and ongoing realization of business process management.  Ensure a robust infrastructure to support effective, efficient, innovative and agile operations. 

* Ensures projects achieves its intended realization.  Support overall change execution through the BPE tool kit.

* Builds BPE/OE capabilities and mindset within the network to empower others to make improvements on their own. Train others in the continuous improvement tools and techniques found in the BPE/OE toolkit.

* Communications:  Ensures GPP project and portfolio communications are aligned and connected to the overall GPP communication strategy. 

Category Lifecycle Process Leader, Director of Procurement

Location:  San Francisco or Basel

Purpose

* This leadership role is responsible for leading a team in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable for design and delivery of the global category management process. 

* This leader has strategic accountability for the overall category management process for GPP, and must work with SRO leaders to ensure the process connects to the Source to Pay Process. 

* Key accountabilities include creation of a GPP category management tool kit and sourcing, supplier relationship management and governance processes.

* This leader will be responsible for creating and implementing an overall outsourcing process, strategic framework and governance management, which will require engagement with GPPLT and key business leaders. 

* This leader will be responsible for creating and implementing the Global eSourcing Program to establish eSourcing as way of working across GPP. 

* Drives sustainable savings and eSourcing process automation across affiliates, sites & GPP functions through partnership and collaboration.

Key Relationships

* GPPLT, and functional teams

* GPP business process owners

* Affiliate Procurement Leaders

* Global/Regional/Affiliate Finance Leaders

* IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 4-5 direct reports with total team of 10-15 employees and contractors .  Expand to 6 direct reports as Outsourcing Strategy and governance is established.

* Ensures the application of the GPP Category Management process is robust and established as a way of working through the Global Pharma Procurement functions. 

* Establishes and manages the Outsourcing process and strategy governance.

* Manages the connection through the coordination of the overall Procurement Processes of Category Lifecycle including Category Management, Contracting, Request to Pay and Master Data processes.   

* Manages the global category management process ensuring toolkit application and practice for both indirect and direct materials processes.  

* Manages process content and training materials for the category management and eSourcing processes.

* Establish and governs the Supplier relationship management and governance processes for GPP categories.

* Owner of the eSourcing Process:  Including improvements, system (IT Solution), Delivery of support and project portfolio.

* Sets up the eSourcing regional support model to support end to end eSourcing processes.

* Drives the adoption of eSourcing tool and processes globally.  

* Raises usage of eSourcing to increase effectiveness (deeper value) and efficiency (faster cycle time) through the use of eSourcing.

* Establishes and monitor global eSourcing targets in conjunction with savings targets.

* Identify eSourcing opportunities in conjunction with the GPP Categories.

* Manages sourcing project content and strategy including: project and bidding strategy, spend segmentation, recommendations for savings implementation, tender development (RFI, RFP, RFQ, auction formats) and managing multiple site project teams.

• The successful candidatewill be responsible for the design, development and implementation of delivery devicesfor parenteral pharmaceutical therapeutics.  Primary technologies in-scope of the role includemanual injection systems, automated injection systems, and interfaces withpre-filled syringes and cartridges.
• Major responsibilitieswill include the development and commercialization of devices includinginterfaces with the primary container.
• This person will be atechnical expert and will provide technical leadership in the development andcommercialization of new drug-device combination products in collaboration withRoche and Genentech's engineering, scientific, and manufacturing organizations.
• He/she will provideguidance and input regarding product development and will regularly interfacewith staff and leaders in Commercial Marketing, Clinical Sciences, ContractManufacturing, Product Core Teams, Pharmaceutical Development, PackagingDevelopment, Quality and Regulatory Affairs.
• He/she will also regularlyinteract with external development partners and component suppliers, and may alsosupervise staff members.

• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

The Demand Planner/Scheduler is the key interface between PTD Stakeholders and Operations and Engineering to build alignment of plant demand & strategy with the production capabilities and supply plans. This person collaborates cross functionally to drive predictable demand for drug substance and drug product to ensure clear requirements for supply planning.

Our goal is to provide unsurpassed customer service within our organization and partners.  As a member of the Supply Chain Management team, Support Services Process Technical Development, you will be responsible for the following tasks:
• Develop, manage, communicate, and plan effectively to ensure alignment with, and clear understanding of strategic and operational goals of our customers.
• Ensure alignment between mid-term and long term plans
• Drive, monitor and ensure achievement of plant key performance metrics
• Review plant performance and agree upon planning parameters for the upcoming cycle
• Participate in projects that are aligned with our business strategy and technology roadmaps
• Provide input into strategic functions for sourcing and/ or investment decisions
• Act as a Single Point of Contact for our customers for relevant Demand Planning topics (Targets / Key Performance Indicators / Service Level Agreements)
• Collaborate on product forecasting process management, identification and management of strategies to manage demand variability and forecast accuracy
• Continuously analyze the forecast, review, check for imbalances and monitor alerts
• Help articulate and communicate demand uncertainties and risks and develop options for optimizing Inventory, replenishment and demand plans to supply planning
• Responsible for defining the suitable planning constraints jointly with team and is accountable that the agreed constraints are implemented
• Responsible to monitor plan stability and drive continuous improvement to targets
• Responsible for managing key parameters / key performance indicators / targets, used in all areas of operations
• Responsible to present on status and issues of plant metrics and escalating risks to management according to defined thresholds

The PD Biometrics and Clinical Sciences Informatics (FPPO) team is looking for a highly skilled Delivery Service Manager, who will support the Biostatistics, EpiPRO, and Thesaurus 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 FPPO management and business clients

• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers and subordinates by consistent application and modeling of the appropriate compliance, behavior and conduct
• If applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2. Planning & Development

• Act as a subject matter expert and a lead contact for FOIM Data Management – Field Operations IMS data sources and Genentech supplemented files production processes and projects
• Stays abreast of Commercial Operations and other business developments, to include external marketplace changes/developments, and uses where appropriate data to support recommendations to improve processes
• Recommends new opportunities to his/her manager and other business partners/stakeholders. Where approved, leads the development/implementation process for such new opportunities
• Works with manager, team members, gCOI, others in FOIM, other internal customers, partners and stakeholders and external vendors to review business requirements for Commercial Operations validation and sales data and plan for any new or updated data sources, systems, databases, interface, processing methods and/or reporting mechanisms
• Works with manager, team members and others to develop appropriate departmental plans and goals to address customer requirements. Where applicable, develops detailed project plans and participates in evaluating necessary resources 
• Participates in other planning and development meetings within FOIM and other Commercial Operations groups
• Participates in departmental policies & procedures development, which may include development and documentation of Standard Operating Procedures (SOPs) or other relevant guidelines. May take the lead role in departmental policies & procedures development, as assigned
• As appropriate and assigned, independently leads departmental or customer projects 

Data Management Manager / Sr. Manager

Data Management Manager / Sr. Managers act as subject matter experts and lead contacts for Commercial Operations’ Customer Master Data. The Master Data Management function and team are responsible for development and management of all Commercial Operations’ Customer Master Data operations and projects, including analyzing and matching master data with customer data, reconciling and validating data, systems or database upgrades and ongoing management, attending to ad hoc data requests, and leading and/or participating in special data projects that impact Commercial Operations’ Customer Master Data. Like other Data Management teams, Master Data Management works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Data Management Manager / Sr. Managers are typically assigned the largest or most complex projects or other operations to support and they may also people management responsibilities for one or more direct reports. Incumbents in the Data Management Manager / Sr. Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. As a manager of others, the Data Management Manager / Sr. Manager 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.

Incumbents in the Data Management Manager / Sr. Manager role are generally expected to:

• Act as lead subject matter expert for Commercial Operations' Master Data Management operations and projects. Including leading and/or otherwise supporting the largest and/or most complex projects or other operations: 

• Identifying new business rules to support best-in-class customer master data
• Expertly leading data analysis, extraction, matching, reconciliation and validation activities with the highest possible levels of accuracy and timeliness
• Consistently complying with all Genentech IT protocols, procedures, standards and other relevant business requirements
• Expertly fulfilling other ad hoc requests and leading special data projects, which includes upgrading and launching new systems or upgrades
• At all times, ensuring all work is completed on-time and on-target to fully meet or exceed expectations, goals and targets
• Developing and maintaining excellent working relationships with customers, partners and other stakeholders; providing the highest quality customer service and following established departmental protocols, policies and procedures

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies
• Manage the overall relationship with master data vendors
• Utilize only approved resources and messages to meet goals and targets
• Where assigned, recruit, hire, and develop direct reports, as well as oversee their work to ensure assigned goals, objectives and targets will be met or exceeded
• Effectively and efficiently train end-users and/or other customers, partners or stakeholders on Commercial Operations’ Customer Master Data operations, content, usage, applications and the like
• Support his/her manager and other team members in training and mentoring less experienced analysts
• Participate, as and when needed or otherwise appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve and excel

The DAS is responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.

Responsible for the production of non-CRF data collection specification documentation 

Defines the study specific non-CRF data handling strategy

Collaborates with SMT to agree on vendor expectations for the collection and transfer of data 

Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data  

Responsible for establishing appropriate transfer methodology with external data provider

Provides transfer methodology training and documentation on non-CRF data for external vendors.

Responsible for configuring the data loading tools based on data collection specifications

Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure

Performs verification and resolves data transmission, file format and loading errors with data providers  

Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorised

Delivers data to external recipients and review bodies via established transfer methodologies

Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system

Coordinates and plans subfunction activities to meet program-level deliverables and timelines

Develops and maintains the subfunction standards for the studies in a program

Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards

Effectively communicates ideas, project goals and status of work and can present to senior management 

Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation

Sets targeted timeframes for  deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome

Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks 

(Note: This description is not intended to be all-inclusive.)
Perform routine cleaning and custodial maintenance duties:
Execute required order of cleaning in a GMP environment.
Be able to execute all documentation required for cleaning in GMP environment.
Maintain floor surfaces (epoxy, Concrete, rubber tile, and sheet vinyl) by scrubbing, stripping, waxing, buffing, sweeping, wet mopping, and dry mopping these floor surfaces.
Operate floor cleaning machines, buffer, scrubbers and Zamboni.
Operate scissor lifts and fork lifts.
Maintain manufacturing areas by cleaning and disinfecting floors, walls and ceilings as required by cleaning documents.
Maintain stainless steel and windows in GMP areas.
Collect and dispose of garbage, including recyclable materials and some hazardous waste.
Move furniture as assigned when necessary.
Maintain bathrooms by cleaning and disinfecting sinks, mirrors, urinals, toilets, showers, and walls when necessary.
Perform miscellaneous tasks including cleaning venetian blinds, fans, humidifiers, windows, walls, drinking fountains, and garbage cans; polishing brass and stainless steel; replacing light bulbs when necessary.

Perform outside maintenance tasks:
Perform snow shoveling and sweeping of sidewalks and stairs when necessary.
Apply deicer to sidewalks and stairs when necessary.

Contract Services Manager 

Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, may perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules 
• Responds to questions/inquiries; may include policies, pricing, payment calculations, contract performance, complianc...

This position may be filled at a Contract Manager  or Sr. Contract Manager level.
 
The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with partners in field Account Management across MCCO Channel and Payer Field teams as well as GNE Government Affairs, reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• As needed, supports field Account Management partners in negotiating contract terms and conditions
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities
•  Business travel, by air or car, is required for regular internal and external business meetings
  

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

Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. 

Provide GMP compliance expertise to internal and external customers.

Perform tasks and work to achieve company goals and organizational objectives.

·         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. 

·         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.

·         Perform any other tasks as requested by Management to support Quality oversight activities.

·         Participates in audits.  Lead audits.  Can develop audit findings that address individual gaps and system gaps.  Can lead all “low risk” and most “high risk” area audits.  Can participate on all high risk audits.  Report requires little or no input from manager.  May be asked to participate in meetings post audit to discuss unresolved issues with Senior Management.

·         Identifies gaps in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations.  Leads teams to remediate or defend identified risks.  Works with customers to develop CAPs and CAs for identified audit findings.  Presents information on outcomes to Sr. Management.

·         Will be assigned compliance opinions.  Needs no guidance from manager on resources / references. Opinion has depth and breadth and requires little or no input from Manager / review team.

·         Identifies gaps in corporate practices, policies and procedures.  Leads efforts to remediate gaps.  Write and or participate in corporate document development.

·         Participates in response development to regulatory inspection observations.  Author responses if assigned. Acts as a SME for GMPC.

·         Participates in FDA Meetings.  Acts as a SME for GMPC.

·         Participate as a GMPC representative in team meetings.  Is a SME on compliance issues. Independently raises compliance issues with the team.  Provides input on issues discussed informing manager of resolution. Communicates issues to manager as necessary.

·         Leads mock PAIs

·         Attends meetin...