Purpose: The purpose of this position is to provide technical quality expertise for the IMP External Quality organization, Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs) and Partners, as well as internal stakeholders. This position will be based in South San Francisco.
Lead Quality Management of assigned CMOs/CROs/Partners, serving as the PTDQX single point of contact. Represent PTDQX on global teams to ensure knowledge sharing within the entire Roche network. Provide guidance for Quality operations, including facility and equipment requirements, for the CMO/CRO network. Focus area includes, but is not limited to, label/pack operations including device assembly.
Mentor and provide guidance functionally and cross-functionally. Manage work activities of peers and contractors for specific projects or objectives as required. Coordinate workload as well as other platform specific activities such as staff meetings.
Serve as quality lead in CMO/CRO selection and Due Diligence assessments for in-licensing events. Support transfer to commercial, and implementation of new technologies as required.
Serve as quality lead for Quality issues associated with Partners.
Draft, negotiate and review Quality Agreements and corresponding Product Specific Requirements for CMOs/CROs/Partners and Investigator Sponsored Trials. Provide quality expertise to ensure roles and responsibilities are appropriate and clear, and requirements of the Quality Agreements are fulfilled.
Provide technical expertise and guidance to the IMP External Quality organization by supporting or managing deviations, investigations, changes, and CAPAs.
Support PTDQX Quality Systems & Business Processes in developing, implementing and maintaining Quality Systems for Quality oversight of CMOs, CROs and Partners.
Develop and maintain quality risk management plans and identify, mitigate, and reduce CMO/CRO quality and compliance risks. Lead CMO/CRO process and quality improvement projects/teams. Present Quality findings to the established review committees as required.
Represent the IMP External Quality organization on TDT Quality Subteams as needed, to include CMO/CRO Quality Systems assessments, assuring cGMP compliance, by:
managing quality risks
tracking appropriate metrics
reviewing/approving MBRs and batch records
reviewing/approving associated deviations, investigations and complaints, including temperature excursions
presenting investigations to the IMP Quality Review Board
addressing quality issues associated with comparators and concomitant medication
supporting QP Declaration and Certification requirements
performing GMP readiness as required
performing person-in-plant activities as required
Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMP, Genentech Policies and Procedures, and the lot disposition schedule. Communicate any delays or significant Quality issues in a timely manner. Address any lot disposition documentation requests in support of clinical trials.
Lead significant global, cross-functional business process improvement projects and multi-platform programs as appropriate, and present results to all stakeholders.
Support cGMP audits and Health Authority inspections as needed.
Manage competing priorities to meet departmental and organizational targets and timelines.
Set performance goals and collaborate with management to establish organizational objectives
Be accountable for behaviors according to the Roche Code of Conduct and company policies and procedures
Who You Are
BS/BA in life sciences or equivalent
At least 12 years experience in manufacturing, quality assurance and/or quality control in the biotechnology or pharmaceutical industry with a sound knowledge of drug development processes
Direct management or project experience in a quality role in bio-pharmaceutical operations desired
Demonstrated working knowledge of Quality Assurance and manufacturing principles
Demonstrated proficiency in interpretations of cGMP regulations, both US and international
Experience in Label/Pack operations desired
Demonstrated problem solving skills using critical thinking, identifying risk based resolutions
Must be capable of applying cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making skills
Proven ability to make sounds decisions regarding scheduling, allocation of resources and managing priorities.
Risk assessment experience and understanding of risk management principles. Familiarity with risk based approaches suitable for bio-pharmaceutical development.
Excellent verbal and written communication skills, including presentations at cross-functional meetings, to senior management and to key external stakeholders
Experience working with third parties and effectively using strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish work.
Demonstrated experience in working effectively with cross-functional teams that may be multicultural and/or global.
Familiarity with computer systems and ability to quickly become familiar with new software (e.g., TrackWise, SAP)
Ability to travel approximately 15% domestic and international.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.