Associate Director, Drug Product Quality Assurance

About the role

The Associate Director for Drug Product Quality Assurance will lead the sterile drug product QA team, ensuring compliance with cGMP, regulatory requirements and company policies while supporting the launch of breakthrough medicines from Delaware.

Key responsibilities

• Lead the sterile Drug Product QA team and oversee batch record review, discrepancy reporting, investigations and CAPAs.
• Ensure GMP compliance for biologics manufacturing, review and approve GMP documentation, and drive continuous improvement initiatives.
• Provide quality oversight for qualification/validation, technical transfers, regulatory approvals and commercial operations.
• Support audit readiness, respond to health authority inspections and prepare regulatory submissions.
• Manage shift specialists and collaborate with global teams on quality systems and processes.

Required profile

• Minimum 10 years experience in Quality Control, Quality Assurance or related pharmaceutical/biological operations.
• At least 5 years operational experience in a regulated environment with tech transfer or process validation exposure.
• Strong knowledge of US and European GMP, ICH guidelines and experience interfacing with regulators.
• Proven analytical, problem‑solving and root‑cause analysis skills with ability to handle multiple priorities.

Required skills

• cGMP and GMP compliance
• ICH guidelines
• Cleaning in Place (CIP), Cleaning out of Place (COP), Sanitize in Place (SIP)
• Continuous improvement tools (DMAIC, Lean QA, 5S)
• Batch record review
• Technical transfer and process validation
• Regulatory submission preparation
• Audit support and inspection readiness