Senior Quality Assurance Manager/Principal Quality Assurance Manager

Company: Genentech
Location: San Francisco
Posted on: March 29, 2025

Job Description:

The PositionThis role is an integral part of our Individualized and Cell Therapy Quality team, dedicated to ensuring that our products and services meet the highest standards of quality and reliability. With a focus on continuous improvement and adherence to regulatory requirements, our team plays a crucial role in safeguarding the excellence and safety of our offerings.The OpportunityAs a Senior Quality Assurance Manager/Principal Quality Assurance Manager, you will play a key individual contributor role in providing comprehensive quality oversight and guidance throughout the end to end manufacturing process of individualized and cell therapy products. This includes overseeing starting materials, Drug Substance, Drug Product, and Finished Goods manufacturing, as well as analytics for in-process and release testing, and, when necessary, bio-specimen collection and shipment. Your responsibilities will encompass ensuring compliance with regulations, contributing to the development of the quality strategy, and delivering innovative quality input and support to technical development teams. Moreover, you will be tasked with overseeing clinical manufacturing operations at partner/CMO organizations and collaborating with cross-functional teams to ensure the successful manufacturing, release, and shipment of life-changing cell and gene therapies to patients. Additionally, you will:

• Contribute to the development of quality strategy for product/platform development
• Represent QA in product and process development activities, including process transfer, validation, and design of new capabilities
• Provide Roche input and approval to partner/CDMO organizations on investigations, deviations, CAPAs, change control, and complaint investigations
• Negotiate, approve, and maintain quality agreements and ensure the requirements of the quality agreement are fulfilled
• Participate in quality review boards and run batch disposition activities in accordance with cGMP and Roche Policies
• Support and participate in compliance audits, Health Authority inspections, and interactions
• Provide timely support for Health Authority interactions and author/review responses to relevant Health Authority information requests
• Perform risk management, monitor Quality and compliance metrics, and review/approve relevant Quality documents for compliance to clinical trial protocol, regulatory filings and product specific requirementsNote: This position may be hired at either a Senior Quality Assurance Manager or Principal Quality Assurance Manager, depending on candidate qualifications.Requirements for Senior Quality Assurance Manager:
  • Possess a Bachelor's degree in life sciences AND a minimum of 8 years of relevant experience in the pharmaceutical industry
  • You have at least 5 years of direct experience in quality assurance operations
  • You demonstrate proficiency in interpreting cGMP regulations and showcasing quality oversight in pharmaceutical operations
  • You have a proven track record of problem-solving, influencing stakeholders, and effectively managing complex situations in a matrix environment
  • Comfortable with ambiguity and capable to think "out of the box" to challenge the status quo
  • Exhibit excellent communication skills with a high level of intercultural awareness and the ability to work effectively in a global setting
  • You are able to travel internationally up to 20%The expected salary range for a Senior Quality Assurance Manager position based on the primary location of California is $137,060 - $245,540. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Requirements for Principal Quality Assurance Manager:
    • Possess a Bachelor's degree in life sciences AND a minimum of 12 years of relevant experience in the pharmaceutical industry
    • You have at least 8 years of direct experience in quality assurance operations
    • You demonstrate proficiency in interpreting cGMP regulations and showcasing quality oversight in pharmaceutical operations
    • You have a proven track record of problem-solving, influencing stakeholders, and effectively managing complex situations in a matrix environment
    • Comfortable with ambiguity and capable to think "out of the box" to challenge the status quo
    • Exhibit excellent communication skills with a high level of intercultural awareness and the ability to work effectively in a global setting
    • You are able to travel internationally up to 20%Preferred Experience:
      • Cell and gene therapy product development/manufacturingThe expected salary range for a Director position based on the primary location of California is $157,850 - $293,150. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Relocation benefits are approved for this posting. This position may be based in either South San Francisco, CA or Hillsboro, OR.
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Keywords: Genentech, San Francisco , Senior Quality Assurance Manager/Principal Quality Assurance Manager, Executive , San Francisco, California