Executive / senior industry position
The head of Microbiology is a member of the Vacaville QC Leadership Team (QCLT), which is accountable for safe and efficient QC operations in full compliance with current GMP’s and Roche’s corporate principles, quality policies and standards.
This role leads a team responsible for the following:
- Performance of microbiological testing of product stream samples to meet product release timelines.
- Performance of environmental and critical utility testing in accordance with cGMP regulations and Roche/Genentech standards.
- Supporting manufacturing operations by timely completion of testing and disposition.
- Continuous improvement of processes and technology, in collaboration with technical teams, to drive right first time and efficiencies.
- Qualification and validation of microbiological test methods.
- Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems.
Leadership and People Management
- Lead and manage all aspects of people processes – organization, staffing, talent management, performance management to meet strategic and operational objectives. Direct staff in setting operational objectives and business goals for their respective areas of responsibility.
- 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.
- As a leader within the QCLT, drive/support network activities and alignment, cross-functional planning, and decision making.
- 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, including servant leadership, while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
- Accountable for overall budget and financial performance for area accountability.
Technical and Functional
- Ensure timely generation and reporting of test results in support of manufacturing operations
- 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 all laboratory operations including test execution, review and data documentation follow cGMP procedures.
- Collaborate with QC Support to ensure calibration and maintenance of laboratory equipment and systems.
- Direct QC Staff in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs
- 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.
- Approve protocols and reports (e.g., third-party QC labs, MSAT or QC studies, etc.).
- Graduate or higher-level degree is preferred
- 4 or more years’ people management experience
- 3 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry
- Expert knowledge of cGMP relevant to the pharmaceutical industry
- Expert knowledge of laboratory safety procedures
- Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
- Expert knowledge in Pharmaceutical Microbiology
- Demonstrate excellent verbal and written communication skills in English
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.
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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.