Quality Capital Programs Director

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