QA Operations Manager

The Manager of QA Operations will lead the quality assurance operations for commercial packaging at Contract Service Providers (CSPs). This role is critical in ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in daily packaging operations.

Key Responsibilities

• Lead QA operations for commercial packaging at CSPs.
• Ensure GMP/GDP compliance in daily packaging operations.
• Review batch records and support lot disposition.
• Conduct QA review of deviations, changes, Corrective and Preventive Actions (CAPAs), and risk assessments.
• Provide input on technology transfer, process validation, and shipping protocols.
• Escalate manufacturing issues and coordinate with Contract Manufacturing Organizations (CMOs).

Requirements & Qualifications

• Bachelor’s degree in a scientific field.
• 6+ years of experience in biopharma with 4+ years in QA operations (cGMP).
• Strong knowledge of FDA regulations (21 CFR 210/211), ICH, and EU directives.
• Experience with serialization in US and global operations.
• Experience with the Veeva platform is preferred.
• Strong communication skills in matrix environments.