Oversee the development and implementation of Quality Control strategy and activities for assigned Site. Oversees generation, review and compliance of locally developed and approved procedures with company-wide quality policies and standards.
Direct staff and operations within Quality Control groups in accordance with cGMP regulations and the Roche/Genentech’s standards
Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control for the site.
Monitor and ensure the performance and delivery of results for the Quality Control testing laboratories.
Provide leadership and guidance to immediate staff performing Quality Control activities. Support can include sampling, sample management, testing of DS, DP, and finished goods (release and stability) as well as raw materials, in-process, devices, direct materials, utilities and environmental monitoring of classified areas as well as retention sample management as defined by site requirements.
Leadership and People Management
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
As a leader within Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision-making.
Accountable for overall budget and financial performance of the Quality Control function.
Engage in proactive measures to promote a positive safety culture while ensuring all-applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
Technical and Functional:
Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures. (e.g., in Germany: Responsible as “Leitung der Qualitätskontrolle, LQK”)
Direct QC Staff in the timely completion of testing (e.g. DS, DP and FINP release and stability testing, raw materials, in process samples, utilities, direct materials, medical devices, environmental monitoring, process and cleaning validation.).
Provide QC staff with technical guidance on test methods and relevant procedures
Ensure timely generation and reporting of test results in support of manufacturing operations (e.g., hold testing).
Ensure calibration and maintenance of laboratory equipment and systems.
Ensure support of manufacturing operations through troubleshooting, transfer activities and other product lifecycle testing.
Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
Ensure system, computer, change control, and analytical data is reviewed, evaluated and approved against established criteria.
Ensure data is generated, documented and reported following cGMP procedures
Direct the review and approval of all applicable Quality Control documents and ensure documents are updated
Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods
Lead Analytical transfers and local analytical method verifications as required by sites
Direct QC Staff in the timely resolution of issues, including discrepancies, investigations, and implementation of CAPA (corrective actions preventive actions)
Escalate any potential quality issues revealed during QC testing or processing of products (e.g., QRB), especially quality or regulatory issues with the potential to affect product quality or regulatory compliance.
Support regulatory inspections and partner audits, approvals of protocols and reports of third party QC laboratories
Liaise with regulatory agencies and external sources regarding issues affecting product quality as QC SME
Global QC, Other site QC leaders, MMTech Boards, ACT/ATL
Who You Are
Bachelor’s Degree (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred)
Graduate or higher-level Degree is preferred
10 or more years’ work experience in the pharmaceutical or related industry
6 or more years’ people management experience
4 or more years’ relevant quality experience in the pharmaceutical industry (quality, analytical sciences, pharmaceutical development, manufacturing, or process development)
Expert knowledge in assay transfer and regulatory submissions
Expert knowledge of cGMP relevant to the pharmaceutical industry; including knowledge of laboratory safety procedures
Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
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.