Director of Manufacturing Operations

Description

This role will serve as the External Manufacturing Quality Lead, ensuring compliance with cGMP clinical requirements, driving inspection readiness, and partnering cross-functionally to support a growing pipeline of advanced therapies. This is a highly visible leadership role with direct impact on clinical timelines and regulatory success.

• Lead and support health authority inspections involving external manufacturing sites
• Lead and develop a team of QA leaders and technical professionals
• Develop, negotiate, and maintain Quality Agreements with CMOs
• Partner cross-functionally with Technical Development, Manufacturing, MSAT, Supply Chain, and Regulatory
• Ensure compliant disposition of materials and clinical cell therapy products
• Establish and review external quality metrics and management review programs
• Perform audits of external manufacturing sites as required
• Act as the Quality lead for external CMOs supporting cell therapy manufacturing
• Provide oversight across Quality Assurance, Quality Systems, and Quality Control at partner sites
• Support tech transfer and product lifecycle activities

Requirements

• Aseptic processing in ISO 5 cleanroom environments
• Experience leading health authority inspections
• Experience with Quality Agreements and tech transfer
• Direct experience supporting cell therapy or advanced therapy medicinal products (ATMPs)
• Proven people leadership experience
• Clinical-stage manufacturing experience
• Willingness to travel up to 50%
• Bachelor’s degree in a scientific or technical discipline
• Familiarity with 21 CFR Parts 210, 211, 1271; 600/601/610 a plus
• Extensive experience with external manufacturing / CMO oversight
• Strong knowledge of cGMPs, ICH guidelines, and FDA/EU regulations
• 14+ years of Quality experience within regulated manufacturing environments

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance