Executive Director, Quality Assurance Operations

Role Summary

Executive Director, Quality Assurance (Operations) with responsibility for QA activities related to Drug Substance manufacturing operations at the Gene Therapy Manufacturing Facility (GTMF) in Bedford, MA. Leads a multi-shift team supporting core Manufacturing activities for Drug Substance, including review/approval of manufacturing records, deviation management, change control, and batch disposition support. Partners with Manufacturing leadership, downstream Drug Product QA, and cross-functional teams to ensure GMP compliance and a state of inspection readiness. Manages performance and development of direct reports to achieve organizational and department goals.

Responsibilities

• Lead the Drug Substance QA operations team to create, deploy and manage processes that ensure product quality during manufacturing operations and compliance with applicable FDA/EMA/global health authority requirements and expectations.
• Approve SOPs/Document Management: instruction sets, specifications, sampling instructions, and other procedures directly related to operations and other cGMP activities.
• Deviation/CAPA Management: ensure deviations are documented and investigated to determine and fix root cause.
• Raw Material Release: ensure assessment and testing support Quality approval/rejection for starting materials, packaging materials, intermediates, bulk and finished product.
• Training: ensure personnel, including contractors, have proper qualifications, skills, education, and training per procedures and regulations.
• Validation/Maintenance: ensure maintenance and qualification of equipment and facilities in area of responsibility.
• Oversee review/approval of GxP documents (protocols, TS, Batch Records, Workbooks, SOPs, QMS documents).
• Ensure capabilities, procedures, and quality mindset support GMP with focus on data integrity/analysis and management.
• Develop and maintain Key Quality Performance Indicators for site Quality operations and implement remediation for out-of-tolerance metrics.
• Set team objectives aligned with business goals and manage targets.
• Manage all aspects of people processes related to the employee life cycle; coach and develop staff with ongoing growth opportunities and regular feedback.
• Participate in inspections and audits as assigned.

Qualifications

• Minimum B.S. degree in scientific field, preferably microbiology, chemistry or biochemistry.
• 15+ years of experience in biopharmaceutical/biotechnology/cell or gene therapy industries with Manufacturing and Quality roles; 10+ years of Quality leadership/management experience.
• Direct experience at a biologic or ATMP manufacturing site; knowledge of drug substance, aseptic processing, and packaging.
• Strong knowledge of domestic and international GMP regulations for biologics/cell/gene therapy products.
• Ability to communicate technical information to senior leadership/health authority inspectors clearly.
• Ability to interface with all levels and departments (Regulatory, Technical Operations, MSAT, Clinical Operations, Supply Chain, PM/Program Management).
• Experience reviewing/authoring CMC sections of regulatory filings and collaborating on product-related investigations/deviations.
• Excellent written and verbal communication, teamwork, interpersonal and negotiation skills.
• Willingness to work in a dynamic environment; flexible to shifting needs/priorities.
• Travel may be required up to 10%; ability to travel to other Boston-area locations for larger team meetings.

Skills

• Quality Assurance leadership and personnel management
• GxP/document management and QA/regulatory compliance
• Deviation/ CAPA management and root-cause analysis
• Material release and batch disposition processes
• Regulatory affairs collaboration and CMC familiarity
• Data integrity, statistics, and quality metrics development
• Cross-functional collaboration (Engineering, Validation, QC, MSAT, Regulatory, Supply Chain)

Education

• Minimum B.S. in a scientific field (microbiology, chemistry, biochemistry or related)

Additional Requirements

• Travel up to 10% as needed