Executive Director, Quality Assurance Operations

The Executive Director, Quality Assurance (Operations) will be responsible for Quality Assurance activities related to Drug Substance manufacturing operations at the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA.  This role will provide leadership and oversight of a team that supports the core Manufacturing activities for Drug Substance across multiple shifts.  Core activities include the review and approval of manufacturing records, deviation management, change record management, and support of batch disposition activities.  This role partners closely with the Manufacturing leadership team, the downstream Drug Product Quality Assurance team, and cross-functionally with Engineering, Validation, QC, Quality Systems, and MSAT functions to ensure GMP product is made in a compliant manner, with a quality mindset, while maintaining a constant state of inspection readiness.  This role is responsible for quality decisions related to Drug Substance manufacturing operations, material/product movement, and multi-product controls at the site.  This role will also manage the performance and development of direct reports to ensure achievement of organizational and department goals within a product and effective environment.   

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Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

• 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/applicable global health authority requirements and expectations.  This is demonstrated through: 

• • SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, and other procedures directly related to operations and other cGMP activities 

• • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause 

• • Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product 

• • Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations 

• • Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility. 

• Oversee the review and approval of GxP documents, including protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, and other Quality Management System (QMS) documentation. 

• Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management 

• Develop and maintain Key Quality Performance Indicators for site Quality operations and design and implement remediation strategies for out of tolerance metrics 

• Set team objectives in alignment with business objectives and ensure that targets are managed. 

• Manage and administer all aspects of people processes related to the employee life cycle. 

• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities. 

• Participate in inspections and audits for various roles as assigned. 

• 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 working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site.  Knowledge and experience with drug substance, aseptic processing, and packaging. 

• Strong knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products 

• Demonstrated ability to communicate technical information or complex situations to senior leadership and/or health authority inspectors in a concise and clear manner 

• Able to interface well with all levels of personnel, including peers and other department heads such as: Regulatory, Technical Operations, MSAT, Clinical Operations, Supply Chain and Project / Program Management. 

• Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with manufacturing operations on product related investigations and deviations. 

• Excellent communications skills, both written and verbal. 

• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally. 

• Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities. 

• Travel may be required up to 10%. Ability to travel to other Boston-area locations for larger team meetings 

Physical Demand Requirements 

General Manufacturing: Drug Substance/Central Svcs: 

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Able to lift, push, pull up to 50lbs. 

• Climb ladders and stairs of various heights. 

• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment. 

• Certain tasks may require the use of a respirator; medical clearance will be required in advance. 

• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment. 

• Working in temperature-controlled environments (cold rooms).  

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