Senior Manager, GMP Quality Assurance

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

Requirements

• Bachelor’s degree in life sciences, chemistry, or related field
• 8+ years of GMP Quality experience in pharma or biotech
• Strong knowledge of global GMP regulations and quality systems
• Proven ability to lead cross-functional initiatives and solve complex problems
• Excellent communication and stakeholder management skills.
• Experience with eQMS (e.g., Veeva) and global markets is a plus.
• Must be authorized to work in the U.S.