Associate Director, GMP Quality

Responsibilities

• Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs, policies, and work instructions.
• Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports.
• Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition.
• Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events.
• Conduct internal audits to assess compliance and identify improvement opportunities.
• Conduct the qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers.
• Review and maintain Quality Agreements, ensuring external partners meet GMP expectations.
• Support preparation for and participation in regulatory inspections and due diligence audits.
• Apply risk management principles (e.g., FMEA) to guide decision-making.
• Champion a culture of quality, transparency, and continuous improvement.
• Explore opportunities to integrate AI technologies to improve efficiency, compliance, and quality assurance practices.

Requirements

• Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences).
• Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing.
• Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety.
• Excellent communication, organization, and collaboration skills.
• Ensures accuracy and completeness in documentation and decision-making.
• Ability to lead investigations and write clear, concise supporting documents.
• Experience with CMO oversight or virtual manufacturing models.
• Thrive in a dynamic, fast-paced environment with evolving priorities.