Associate Director, QA Manufacturing Technical Services

Key Duties & Responsibilities

• Lead, execute, and oversee the deviation management process across all stages of manufacturing, from identification to closure.
• Ensure proper investigation, documentation, and resolution of all deviations in accordance with internal policies and regulatory requirements.
• Provide quality and technical expertise in the investigation of deviations including OOS/OOTs, conduct thorough root cause analysis to identify underlying issues, and oversee efficient and effective implementation of corrective and preventive actions (CAPA) to prevent recurrence.
• Partner closely with Manufacturing, Quality Control, MSAT, Engineering, Supply Chain, Regulatory Affairs, and other Quality functions to ensure timely and effective resolution of deviations and alignment with patient safety, product quality, and regulatory compliance.
• Maintain awareness of and ensure compliance with industry best practices and regulatory guidelines.
• Establish and maintain deviation tracking systems, ensuring that all deviations are properly documented, categorized, and monitored for timely resolution.
• Prepare and present regular reports on deviation metrics to senior leadership.
• Lead and execute continuous improvement activities and drive quality remediation.
• Support risk assessments to evaluate the impact of deviations on product quality, safety, and regulatory compliance.
• Ensure that all deviation records are maintained in a compliant and audit-ready manner.
• Lead or support internal and external audits related to deviation management, ensuring all required documentation is available and accurate.
• Participate in operational review and escalation meetings to ensure Quality issues are appropriately raised, assessed, and addressed in support of internal manufacturing operations.
• Provide routine on-the-floor Quality support for manufacturing operations, including real-time troubleshooting, batch execution support, escalation of quality issues, and guidance to operations personnel to ensure compliance with procedures and cGMP requirements.
• Serve as a visible Quality presence in manufacturing areas to facilitate compliant and rapid resolution of issues.
• Participate in Cell & Genetic Program and Quality projects.

Knowledge And Skills

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Broad technical knowledge in cell technology, aseptic manufacturing operations, analytical assays, cell & genetic therapies/biologics processing, fill/finish, and testing, with the ability to apply that knowledge in support of internal manufacturing operations.
• In-depth knowledge of deviations, root cause analysis, CAPA, and change control processes.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Substantial experience with electronic document management systems (e.g., Trackwise, Veeva).
• Excellent communication skills with the ability to present complex information and a proven track record of influencing, building, and promoting a culture of Quality and Excellence across manufacturing operations and on the production floor.
• Strong leadership and an innate ability to collaborate and build relationships.

Education And Experience

• Bachelor's degree in a biotech/life sciences field.
• Master's degree or relevant comparable background.
• Typically requires 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.