Sr. Manager, GMP Quality Assurance

We are seeking a Senior Manager, GMP Quality Assurance to support and continuously improve Quality Systems across clinical and commercial products. This role provides leadership across internal teams and external partners to ensure compliance with global GMP/GDP regulations and company standards.

Key Responsibilities

• Lead batch release activities, including review/approval of batch records and material disposition
• Provide GMP oversight for manufacturing and distribution partners (DS, DP, and supply chain)
• Ensure compliance with global regulations (FDA, EMA, ICH)
• Manage investigations, deviations, CAPA, and change controls
• Support audits, inspections, and annual product reviews
• Drive quality system improvements and track key quality metrics
• Partner with CMOs and suppliers on validation, tech transfer, and qualification activities
• Mentor and develop junior QA staff
full-time Operations Specialties Managers