Manufacturing Process & Technical Quality Associate Director, CGT

Manufacturing Process & Technical Quality Associate Director, CGT

The Manufacturing Process & Technical Quality Associate Director is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This includes establishing relevant product quality standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying product quality risks and mitigations throughout development for the assigned programs.

The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects and associated governance to meet business, regulatory and operational requirements.

• Lead and/or participate in the development and implementation of Quality compliance principles throughout product lifecycle management within the Cell & Genetic Therapies product portfolio
• Lead and/or participate in the development and implementation of CMC Quality standards for products and processes for stage gate deliverable, embedding the principles of product lifecycle and Quality by Design.
• Work with cross-functional partners for the risk identification, resolution of issues, OOS, and risk /gap mitigation.
• Ensure quality and compliance frameworks, guidance, and systems are in place to keep the products current with industry and health authority regulatory expectations as well as Vertex's QMS for products throughout the life cycle development.
• Work with development functions and commercial supply chain to drive manufacturing and compliance continuous improvements throughout the clinical development to commercial life cycle.
• Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing. Partner with stakeholders to mitigate the identified risks and implement associated actions throughout product life cycle.
• Serve as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) Governance teams covering Process Development, Technical Operations, and Supply Chain topics for technical transfers, new product introduction across a product life cycle to assure a compliant strategy is developed, executed and maintained.
• Participate in appropriate governance meetings for Quality members to critically review proposed complex changes, assure compliance to regulatory requirements, and drive standardized processes across sites.
• Support investigations, preparation of specifications, CMC clinical and commercial regulatory submissions.
• Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• Lead and mentor team members, support development of organizational capabilities and talent building

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).
• In depth experience in all stages of clinical product development to commercialization product life cycle management.
• Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
• Broad technical knowledge in AAV/Cell technology, aseptic processing, process development, manufacturing science & technology, etc.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply critical thinking and problem solving skills to decision making and operational priorities.
• Strong leadership and an innate ability to mentor, collaborate and build relationships.
• Demonstrated influential leadership experienced operating in a matrix organization through presenting, influencing, negotiation and partnering is required. Capable of building alignment across…