GENERAL SUMMARY:

The Associate Director, Manufacturing Technical Services, Quality Assurance 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. This is the lead role that will drive comprehensive QMS monitoring and tracking for dedicated CDMO(s).
The role is responsible for the development and maintenance of relationships with the external vendors, to drive compliance, monitor performance and support continuous improvement activities.
The quality 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.

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
• Experience in aseptic manufacturing to help assess manufacturing non-conformances robustly.
• 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 and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Effective communicator with the ability to present complex information to senior leadership and external stakeholders
• 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.
• 20% Travel required internationally.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a biotech/Life sciences field.Master’s degree or relevant comparable background.
• Extensive industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
  

  LI-Hybrid

• Lead 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 technical expertise in the investigation of deviations, ability to conduct thorough root cause analysis to identify underlying issues and overseeing efficient and effective implementation of corrective and preventive actions (CAPA) to prevent recurrence. Support root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Ensure that the RCA and investigations are thoroughly conducted based on good understanding of the manufacturing process, impact on the product quality and patient safety.
• 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. Leads/executes continuous improvement activities and drive quality remediation.
• Provide training and guidance to team members and cross-functional departments on deviation management, investigation techniques, and regulatory requirements. Foster a culture of quality and compliance across the organization.
• Identify potential risks related to deviations and work proactively to mitigate risks. 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.
• Cross-Functional Collaboration: Work 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. Build strategic relationships with CMOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
• Lead/Support/Execute Quality oversight for clinical and commercialization QMS activities.
• 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.