Quality Engineering & Validation (QEV) has an exciting position available. The role is responsible for providing technical and quality oversight of process validation activities, ensuring study design and execution are fully compliant with Roche PQS and regulations. This role provides guidance and develops solutions to complex Quality, process, and equipment validation initiatives with inter-organizational impact which enables timely and compliant clinical campaigns through product launch across DP and DS. Responsibilities include:
Review/Approve validation lifecycle deliverables as authorized and described by Genentech policies, procedures
Apply lean principles and LPS tools and methodologies to drive department and cross-functional process improvements
Provide technical and quality review and approve validation deliverables for DS and DP process validation and process monitoring
Utilize coaching and problem solving approach to Influence the design phase of CAPEX projects and PV studies
Provide guidance to internal and external customers on best practices for generating and executing Validation and Qualification
Apply extensive knowledge of technical & validation (PQS) standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to Quality Systems & Validation
Implement and maintain the PQS as it pertains to systems & process validation for SSFP
Build and maintain effective, collaborative relationships across site and network, influencing site and network validation life cycle programs
Provide technical assessment and approval for process & equipment changes
Support investigations with potential validation impact, developing comprehensive action plans
Provide input to revised and new policies and procedures to effectively guide validation efforts
Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems
Notify Management of potential validation or regulatory issues that may affect product quality or regulatory compliance
Serve as the Quality Engineering representative or team lead on cross-functional and multi-site teams
Collaborate with departments to ensure validation activities are executed efficiently and effectively
Present Qualification and Validation topics to auditors, inspectors, and regulatory agencies
Lead the identification, design and implementation of department and cross-functional process/system improvement initiatives
Oversight and approval of Periodic Qualification Review & Requalification deliverables, ensuring maintenance of the validated state
The right candidate will possess the following skills and experience. The level of the position will depend on the qualifications of the selected candidate.
Bachelor's degree, preferably in an Engineering or Life Science discipline.
5+ years of post-Bachelor's experience in the biopharmaceutical industry, or combination of an advanced degree and relevant experience. 8+ years required for the Sr. Technical Manager level.
Experience authoring, reviewing and approving qualification or validation deliverables
Sound knowledge of cGMPs and guidelines set forth in ICH Q8,9,10.
Solid technical understanding of GMP manufacturing processes and equipment.
Ability to interpret and relate Quality standards for implementation and review.
Ability to make sound decisions to address a broad range of problems based on Quality and scientific rationale.
Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain complex issues and concepts with simplicity to a broad audience.
Strong independent problem solving capability.
Flexibility to adjust work hours to meet the needs of the business.
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.