GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
Cell Therapy • Gene Therapy • Synthetic Biology
11 - 50
Sr. Manager / Associate Director, Quality Assurance Operations
July 18
🏢 In-office - Bay Area
GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
Cell Therapy • Gene Therapy • Synthetic Biology
11 - 50
Description
• Critical role providing Quality oversight of Alameda manufacturing facility • Support Manufacturing, Laboratory, and Warehouse Operations • Serve as a subject matter expert for Health Authority inspections • Support new product introduction activities • Quality oversight activities for deviations, CAPAs, change controls, and laboratory investigations • Manage vendor-initiated changes impacting the site
Requirements
• BA or BS in life science degree • 8+ years of experience in pharmaceutical or biotechnology industry • Demonstrated experience in Quality Operations functions within a GMP facility • Extensive knowledge of cGMPs • Excellent written, verbal communication and presentation skills
Benefits
• Provide leadership for Quality oversight of cGMP operations • Execute and improve process and procedures for batch record review • Support risk management activities and approve risk management reports • Serve as subject matter expert and support communications with customers • Collaborate with Quality Validation to support oversight of facilities and engineering processes • Manage performance and development of direct reports
Apply Now
