Job Description

Position Summary:

A clinical-stage biotechnology company is seeking an Associate Director of GMP Quality Assurance . Based in South San Francisco, California, the company is focused on developing therapies that treat immunological diseases and cancer. The Associate Director will report to the Head of Quality and collaborate with cross-functional teams to manage external vendors and CDMOs. The role will involve providing quality support and contributing to the development of the company’s quality systems, with a strong focus on GMP and related regulations.

Key Responsibilities:

• Serve as the technical expert on CGMP-related regulations and guidelines, particularly for manufacturing, testing, and controls.
• Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines.
• Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits.
• Participate in CDMO team meetings, providing quality feedback and collaborating on complex investigations for the company’s global product network.
• Ensure collection, review, and analysis of data for internal and external metrics.
• Provide guidance, review, and impact assessments for change controls and CAPAs.
• Assist in implementing CGMP and GLP activities in compliance with internal procedures and regulatory requirements.
• Participate in quality system and product review meetings, offering quality reviews of key CMC and IND documents while ensuring data integrity compliance.
• Represent Quality on project teams, Health Authority Inspections, supplier and CDMO meetings, and QA to QA discussions.
• Work with the Quality Person (QP) to support key document development and approval.
• Opportunity to gain hands-on experience with GCP-focused projects, including potential involvement in auditing activities.
• Foster a strong quality mindset and a culture of excellence across the organization.
• Lead and promote a collaborative culture aligned with the company’s core values.

Knowledge/Skills/Abilities:

• Strong decision-making skills in complex supply, compliance, technical, and regulatory situations, with an ability to manage ambiguity.
• Hands-on experience in manufacturing, analytical testing, and development.
• Proven track record in working with suppliers and CDMOs.
• Expertise in implementing and managing Quality Management Systems, including paper-based systems and Celito EDMS in biotech/pharma.
• Strong experience with biologics/large molecule modalities
• In-depth knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance.
• Experienced in developing Quality Management Systems (QMS ) and interpreting regulations to build and maintain compliant systems.
• Excellent verbal and written communication skills.
• Strong collaborative, analytical, and interpretative abilities.
• Self-sufficient with the ability to prioritize and meet deadlines.
• Experience working with cross-functional teams.
• Some travel required (around 10%).

Education & Professional Experience:

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field.
• Minimum of 5 years of CGMP Quality Assurance experience.
• Knowledge in clinical development from phase II/III to commercial is desired.

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