Associate Director, Quality Assurance CMO Management (Hybrid)

Job Description

The Associate Director, Quality Assurance CMO Management is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the management of quality management system (QMS) events.  The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring, and deviation management.  The role is also responsible for the development and maintenance of relationships with the internal and external partners, to drive compliance, monitor performance, and support continuous improvement activities.

The role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of the QMS.  The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.

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 other departments, including CDMOs, External manufacturing, QC, MSAT, Regulatory Affairs, and other Quality functions to ensure timely and effective resolution of deviations and alignment with patient safety and product compliance.
• Ensure that all deviation investigations comply with relevant regulatory standards (such as FDA, EMA, cGMP) and company policies. 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.
• Identify potential risks and trends related to deviations and work proactively to mitigate such risks with preventive measures.
• 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 Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
• Provide guidance and support through Quality representation in relevant geographies at periodic intervals on site at the CDMOs.
• 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.
• Experience in product life cycle from discovery to commercials product development
• Broad understanding of regulatory environment, including quality systems, compliance, and strategy.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish, and testing.
• 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., QDoccs, Trackwise, Veeva)
• Excellent communication skills with the ability to present complex information and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision-making and operational priorities.
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers.
• Critical Thinking and Problem-Solving skills
• Strong leadership and an innate ability to collaborate and build relationships.

Education and Experience:

• Bachelor's degree in a biotech/life sciences field.
• Master