Senior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid)

Vertex Inc. • Boston, MA

18h • $216,000 - $324,000 • Hybrid

About The Position

The Senior Director, Manufacturing Technical Sciences QA 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 quality oversight of new process and product development, establishing relevant quality standards, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying quality risks and mitigations throughout the life cycle for the assigned programs. The role will lead a team of process and analytical QA personnel and closely partner with operational stakeholders to participate in Cell & Genetic therapies projects, quality oversight of technical change management from initiation to implementation and closure, and associated governance to meet business, regulatory and operational requirements. This is a HYBRID role, requiring a minimum of 3 days per week on site in the Boston Seaport

Requirements

• Bachelor's degree or Master's degree in a biotech/technical life science/engineering discipline.
• Typically requires 15+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment
• A minimum of 10 years leadership experience leading teams or directing allocation of resources.
• Previous experience on a Site Leadership Team and/or Quality Leadership Team
• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).
• Quality experience of on-site manufacturing as well as CDMO oversight.
• In depth experience in all stages of clinical development to commercialization product life cycle management.
• Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
• Broad technical knowledge in Cell technology, aseptic processing, process & analytical 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 diverse perspectives and functional areas.
• 15% Travel required internationally.

Responsibilities

• Lead, develop, and implement Quality compliance principles throughout lifecycle management within the Cell & Genetic Therapies product portfolio and drive standardized processes across external and internal manufacturing sites.
• Lead, develop & implement CMC and Analytical Quality standards for products and processes for stage gate deliverable, embedding the principles of product lifecycle.
• Proactively maintain Quality Assurance oversight for analytical development, and technical quality activities for the applicable methods/program.
• Participate/Lead QA technical oversight through Change Management to critically review proposed complex changes assure regulatory and product submission compliance pre and post change implementation.
• Serve as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) team for Analytical and Process Development for technical transfers, new product introduction to assure compliance to the established product quality strategy.
• Responsible for the QA oversight of the stability program to assure compliance with internal Vertex procedures and EU/US regulatory standards.
• 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.
• 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.
• Support complex and OOS investigations, preparation of the justification 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 drive corrective/preventive actions.
• Lead and mentor team members, support development of organizational capabilities and talent building.
• Prepare, maintain and manage to budget allocation.

Benefits

• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director