Sr Quality Assurance Manager

12-Month Contract | Full-Time (40 hours/week)

Our client, a growing biotech company in South San Francisco, is looking for a Senior Manager, GMP Quality Assurance to join their team on a 12-month contract.

This role will support GMP Quality Assurance activities across clinical and commercial manufacturing
, with a focus on product release, batch record review, deviations, temperature excursions, change controls, supplier qualification, GMP documentation, and cross-functional CMC support.

Experience with
GMP manufacturing and electronic document management systems, preferably Veeva Vault
, is highly relevant to this role.

• Support product release activities, including review and approval of executed batch records (EBRs) for drug substance and drug product.
• Prepare internal product disposition documentation as required.
• Manage internal and external deviations, temperature excursions, and change control processes.
• Manage the GMP supplier qualification process, ensuring completion and appropriate archiving of qualification records.
• Ensure GMP documents are properly managed and archived within Veeva Vault.
• Support the implementation and revision of Standard Operating Procedures (SOPs) and other GMP documentation as assigned.
• Participate in internal and external CMC project meetings and provide QA support as needed.
• Ensure GMP compliance with applicable regulations, guidelines, and company procedures.
• Participate in inspection readiness activities and support regulatory inspections as needed.
• Curate, track, and report quality metrics as needed.
• Work closely with cross-functional stakeholders and external GMP partners to support quality objectives.

• Bachelor's degree or higher required; degree in a scientific, technical, or related field preferred.
• Minimum of 8 years of GMP experience in pharmaceutical or biotech manufacturing, including experience supporting both clinical and commercial manufacturing.
• 6-7+ years of experience specifically within GMP Quality Assurance.
• Demonstrated knowledge of GMP QA principles, global guidelines, and applicable regulations, particularly those related to manufacturing and handling of investigational products.
• Understanding of QP release requirements and activities.
• Experience working with GMP vendors, including contract manufacturing organizations (CMOs) and/or contract testing laboratories (CTLs).
• Experience with electronic document management systems;
  Veeva Vault experience is preferred.
• Experience with both small molecules and large molecules/biologics is desirable.

• Strong critical thinking, judgment, and problem-solving skills.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to build and maintain positive working relationships with cross-functional stakeholders.
• Self-motivated and adaptable to a dynamic and diverse biotech environment.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and work independently.
• Flexibility to support a variety of activities within the QA team as needed.

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where in operation.