Quality Capital Programs Director

Job Summary

Seeking an Associate Director, Quality Capital Programs, to work virtually on a contract basis, who will manage quality assurance oversight from the design phase through commissioning and qualification for sterile manufacturing capital programs while collaborating with cross-functional teams to ensure compliance with GMP and contamination control standards.

Key responsibilities:

• Provide quality oversight during the design and commissioning phases of sterile manufacturing capital programs
• Lead GMP design review risk assessments and ensure compliance with regional and global regulations
• Collaborate with project team members and engineering to achieve quality deliverables and integrate feedback from audits

Required qualifications:

• Bachelor's or Master's degree in Microbiology, relevant Science, or Engineering discipline
• Minimum 10 years of relevant experience in aseptic manufacturing and QC Microbiology
• Strong understanding of pharmaceutical regulatory requirements and contamination control strategies
• Experience with risk-based qualification and quality risk management
• Excellent organizational skills and ability to manage multiple programs effectively