Executive Director, Quality Assurance Operations

Position Summary:

The Executive Director Quality Assurance (Operations) willbe responsible forQuality Assurance activities related to Drug Substance manufacturing operations at the Gene Therapy Manufacturing Facility (GTMF)locatedin 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 managementchangerecord 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 roleis responsible forquality 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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Work Model:

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.

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/applicable global health authority requirements and isdemonstratedthrough:

• • SOPs/Document Management: Approve all instruction sets specifications sampling instructions and other proceduresdirectly relatedto operations and other cGMP activities

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

• • Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection asappropriate 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 jobin accordance withapplicable procedures and regulations

• • Validation/Maintenance: Ensureappropriate maintenanceand a state of qualification ismaintainedfor equipment and facilities inareaof responsibility.

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

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

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

• Set teamobjectivesin alignment with businessobjectivesand ensure that targets are managed.

• Manage and administer all aspects ofpeopleprocesses related to the employee life cycle.

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

• Participate ininspections and audits for various roles as assigned.

Requirements:

• MinimumB.S. degree in scientific field preferably microbiologychemistryor 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 and experience with drugsubstance 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 tointerface well withall 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.

• Excellentcommunicationsskills both written and verbal.

• Excellent teamwork interpersonalskillsand 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 berequiredup to 10%. Ability to travel to other Boston-area locations for larger team meetings

Physical Demand Requirements

General Manufacturing: Drug Substance/CentralSvcs:

• 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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