MEDICAL DIRECTOR/MEDICAL DIRECTOR - 

RESPONSIBILITIES:

Genentech is seeking a Medical Director with clinical and drug
development experience within our Development-Immunology organization. This individual will be responsible for strategic clinical
oversight with a focus on our scleroderma portfolio. The position will involve clinical development of novel agents. The Medical Director will be responsible for the design, implementation,
monitoring, analysis, and reporting of studies conducted within one or more programs.
They will also participate in developing the long-range strategic plans for the molecule or molecules.

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

The Principal HR Business Partner is the "local" HR business partner for the Finance and Procurement organizations based in South San Francisco and is part of the Corporate Groups HR and Employee Relations team.  This role is the strategic business partner to leaders and leadership teams within the client organizations, including one Genentech Executive Committee member.  This position will have to manage complex/matrix relationships on both a local and global level, collaborating effectively across business and HR networks/partners. 

The person in this role will consult, advise, coach and partner with the business on people and organizational needs -- ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy.  This role also partners with leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business whilst taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

(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.

Planning Lead, Access Solutions Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Lead has an advanced knowledge base regarding Operational Quality and/or Healthcare Compliance and Privacy. This position is responsible assisting in the maintenance of all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, and the management of external business partners. Additional key responsibilities of this role are: quality and compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization as a subject matter expert on compliance related matters.

• Shares responsibility for monitoring, review and analysis of quality and general compliance for all Access Solutions operational entities. Relied upon for sound compliance guidance.
• Assists in the integration of quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations
• Assist in the management of outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• With limited oversight, develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as a team member for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on compliance matters of low to medium risk.

• Close collaboration/partnership with the Product Development operational staff
• Facilitation of subject matter experts within and outside PDG
• Close liaison with PDQ (global quality group)

• Continuous Improvement
• Training Compliance
• Facilitation of simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Records compliance

• Close collaboration/partnership with the PD Operational staff
• Facilitation of subject matter experts within and outside PDG
• Strategic liaison with PDQ (global quality group)
• Staying abreast of internal and external developments, trends and other dynamics relevant to the quality and efficiency of PDG

• Continuous Improvement
• Training Compliance
• Facilitating simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Lead and/or supervise other key projects as required

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

The TrackWise Center of Excellence is looking for a highly skilled Computer Systems Validation (CSV) and Software Quality Assurance (SQA) analyst able to perform within the multicultural team supporting numerous GxP TrackWise processes.  We are seeking an expert in GxP computer validation, 21 CFR Part 11 and Annex 11 requirements, and possessing excellent interpersonal, communication and critical thinking skills.

Job Responsibilities:

• Provide estimates and forecasting for CSV and SQA project resource needs
• Assist in developing and approving computerized systems requirements and functional specifications
• Create GxP deliverables such as validation master plans, test plans, installation, operation and performance qualifications (IQ\OQ\PQ), test scripts, validation summary reports, risk control strategies and risk assessments for changes to validated systems
• Conduct system testing for emergency, and maintenance and enhancement releases
• Document and provide feedback to development teams on issues and bugs identified during testing
• Maintain accurate bug tracking and issues resolution logs
• Develop and execute manual and/or automated test documentation in accordance with approved processes and established standards, and in compliance with applicable regulatory expectations 
• Document test results and work with development teams to resolve test deviations; perform root cause analyses
• Develop new processes and process improvements
• Coordinate with cross-functional teams including Quality to ensure accuracy of all testing documentation
• Partner with development teams to support installation activities and configuration management
• Escalate issues and deviations as needed to management
• Provide subject-matter expertise on software quality assurance best practices, regulatory expectations and 21 CFR Part 11 and Annex 11 requirements
• Liaison with Quality to ensure compliance with corporate policies and procedures (SOPs)
• Oversee contract validation personnel
  
  

• Serve as the Site Manager overseeing clinical contract manufacturing organizations (CMOs) or clinical distribution organizations (CDOs) that are needed to meet clinical supply requirements in supporting clinical labeling and packaging. 
• Lead and collaborate with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives in addition to performance goals for the contract manufacturing or business partnerships.
• Manage the operational activities of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. 
• Develop solutions to complex issues with inter-organizational impact.
• Prepare Requests for Proposals (RFPs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
• Support development and continuous improvement of the supply relationship with IMP CMOs/partners.
• Position may be filled as an E3 or E4 depending on candidate’s experience and qualifications.

Responsibilities:

• Responsible for overseeing execution activities of clinical contracting manufacturing organizations (CMOs) to support labeling and packaging outsourcing activities for clinical studies. Scope is from release of DP at the Filling site through release of Final Packaged Goods at the label/pack site; scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary DP materials and FG components are available for execution.
• Ensure reliable supplies of Final Packaged Drug Product (including Other Study Drugs as required) to our customers and our patients, while meeting acceptable quality standards and Genentech’s financial and development goals.  Proactively intercede if goals and timelines are jeopardized.
• Coordinate operational activities with internal cross-functional teams (Clinical Planning, External Quality, Distribution) to ensure on time release of packaged clinical product.
• Participate on cross-functional teams in evaluating and selecting CMOs for a particular project as requested. 
• Prepare a Statement of Work (SOW) as required.  The preparation of an SOW can include negotiation of project fees, negotiation of milestones, defining responsibilities between Genentech and the CMO and keeping Legal, Procurement and other groups up to date on SOW progress.
• Provide input to the internal CMO/partner SPOC ensuring that the overall relationship between Genentech and the CMO/partner is healthy. 
• Develop, maintain and drive key health metrics between GNE and the CMO to ensure effective and continuous improvement of business performance and relationship.
• Participate in Master Service Agreement creation and maintenance as requested so that it accurately reflects the existing business relationship.
• Proactively identify risks.  Create strategies to avoid or minimize their impact.  Manage the execution of risk mitigation plans. Participate in and contribute to drug development telecons in an effort to proactively intercede if a relationship issue jeopardizes the project.
• Create purchase orders.  Review and approve invoices for GNE payment and coordinate on-time CMO payments.  Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis.
• Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
• Report as needed on performance and operations at Operations Review.
• Support External QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• International and domestic travel as required. 

Requirements:

• Collaborative Leadership - Ability to strongly influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.
• Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly.
• Communication - Ability to communicate effectively at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity.
• Planning/Organization - Excel...

• 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 

Analytical Operations provides assay support for Process Technical Development in GMP and R&D environments.  The hire will be mainly responsible for performing HPLC, CE and LC/MS assays, data processing, and development of HPLC methods. Responsibilities also include assay reagent and instrument maintenance, and assay troubleshooting.  Position requires working closely with other members of the department in a team setting, as well as extensive interaction with other departments. Handling of biological and chemical reagents is required.

The position:

The Senior Engineer in the Process and Project Engineering Group in the South San Francisco Production Technology Department will be responsible for Process Engineering (Process Equipment Design) and Project Management of Drug Product projects for the SSF Production Business Unit.   The support areas include commercial and clinical filling lines, inspection and clinical packaging.  The candidate must also provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  In addition, the candidate will provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms, Engineering Design Review and Engineering Change Records.  The candidate will be responsible for development of business systems to support efficiency and sustainability.  The candidate will also help provide strategic direction to transformation of the Drug Product manufacturing capabilities.