Senior GMP QA Manager (12-Month Contract) - Biotech

Meet Life Sciences; San Francisco (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Meet Life Sciences in South San Francisco seeks a Senior Manager, GMP Quality Assurance for a 12-month contract. You will oversee QA activities across clinical and commercial manufacturing, focusing on product release, batch record review, deviations, change controls, and CMC support.

Experience with GMP manufacturing and electronic document management systems (Veeva Vault preferred) is highly relevant. You will collaborate with cross-functional teams and external partners to ensure compliance

Qualifications

• Bachelor's degree in a scientific, technical, or related field.
• 8+ years of GMP experience in pharmaceutical or biotech manufacturing.
• 6-7+ years of GMP Quality Assurance experience.
• Knowledge of GMP QA principles, global guidelines and regulations.
• Understanding of QP release requirements and activities.
• Experience with GMP vendors including CMOs/CTLs.
• Experience with electronic document management systems (Veeva Vault preferred).

Responsibilities

• Support product release activities, including review/approval of batch records for drug substance and drug product.
• Prepare internal product disposition documentation as required.
• Manage deviations, temperature excursions, and change controls.
• Manage GMP supplier qualification and qualification records.
• Ensure GMP documents are archived in Veeva Vault.
• Support SOP implementation and GMP documentation updates.
• Participate in CMC project meetings and QA support.
• Ensure GMP compliance with regulations and company procedures.
• Assist in inspection readiness and regulatory inspections.
• Track and report quality metrics; collaborate with cross-functional partners.

Skills

GMP Quality Assurance

QP release

Veeva Vault

Electronic document management systems

Vendor management (CMOs/CTLs)

Education

Bachelor's degree or higher

Tools

Veeva Vault

Job description

Meet Life Sciences in South San Francisco seeks a Senior Manager, GMP Quality Assurance for a 12-month contract. You will oversee QA activities across clinical and commercial manufacturing, focusing on product release, batch record review, deviations, change controls, and CMC support.

Experience with GMP manufacturing and electronic document management systems (Veeva Vault preferred) is highly relevant. You will collaborate with cross-functional teams and external partners to ensure compliance