Director Sterile Operational Quality Assurance

Your Skills and Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field; Master’s degree preferred.
• 12+ years of experience in pharmaceutical Quality Assurance, with at least 7 years in sterile / aseptic operations.
• Proven experience leading QA teams and managing complex sterile production environments.
• Strong knowledge of global GxP regulations (FDA, EU GMP, ICH) and sterile manufacturing regulatory expectations.
• Demonstrated success in inspection management and regulatory interaction.
• Experience with global Quality Management Systems (e.g., Veeva, TrackWise).