The Role:

The Director of QA Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of the cell and gene therapy products at our BaseCamp facility in Waltham, MA. This role provides leadership to ensure that cGMPs are maintained and product is manufactured at the highest quality. This individual will implement and continuously improve policies, standards, procedures, practices and systems to ensure manufacturing operations are compliant with global cGMP regulations. The incumbent manages the team responsible for providing day-to-day Quality oversight of clinical manufacturing operations, including QA review and approval of Batch Records, Deviations, Laboratory Investigations, Lot Disposition, and providing on-the-manufacturing-floor QA support.

Here’s What You’ll Do:

• Lead a team of QA managers and individual contributors to support routine cGMP operations with an effective QA on-the-floor support function for critical cell and gene therapy manufacturing activities, bringing a strong compliance and quality mindset to a complex manufacturing environment.
• Ensure cohesive collaboration across QA Operations and Manufacturing for thorough and timely review of manufacturing records, enabling right-first-time batch record review and on-time batch disposition with a high level of efficiency and quality.
• Interface with internal and external clients regarding Quality Assurance, Product Lifecycle and continuous improvement topics.
• Collaborate with QA Validation, Manufacturing Science & Technology, Manufacturing, Facilities & Engineering, and QC for the successful technical transfer of manufacturing processes into routine production, leveraging risk management tools to identify operational risks and associated mitigation control strategies.
• Responsible for the management of the cross-functional sterility assurance and contamination control program.
• Participate with other Quality functions and Management for client interactions and communications.
• Establish and communicate performance objectives for QA Operations staff that are consistent with corporate and Quality goals and objectives.
• Provide training, constructive feedback and a collaborative environment that attracts, develops and retains the best talent
• Develop, monitor and improve Quality policies, procedures and processes to meet cGMP regulatory guidance and the growing needs of the organization
• Foster a quality mindset by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Lead and manage complex projects/teams within corporate objectives and project timelines and participate in cross-functional projects as a Quality subject matter expert.

Requirements:

• Bachelor’s degree in a scientific discipline with at least 12 years of experience in a pharmaceutical, biotechnology or biologics operation, including 7 years of Quality experience.
• Experience with manufacturing of Cell & Gene Therapy Products and with Sterility Assurance Programs preferred.
• Experience in working in a Contract Manufacturing environment preferred.
• Working knowledge and demonstrated ability to apply GMPs across early and late clinical phases.
• Excellent communication skills with a customer service mindset.
• Strong leadership, teamwork and problem-solving skills.
• Experience leading and training others in root cause investigations, deviations, OOS and CAPA.
• Strong knowledge with aseptic manufacturing process requirements
• Technical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).