Director, Materials Management, Product Quality (Onsite)

The Director, Materials Management (Product Quality) is accountable for quality oversight for onboarding, qualification, and release of materials (e.g, raw materials, consumables, etc.) supporting cell and gene therapy programs throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This oversight includes setting and maintaining overall oversight of vendor status for incoming and existing materials, raw material and consumable life cycle management including internal and vendor change notifications, and support of phase-appropriate qualification requirements.

Key Duties and Responsibilities:

• Lead, develop, and implement Quality strategy and compliance principles throughout materials management within the Cell & Genetic Therapies product portfolio (clinical and commercial to keep the products current with industry and health authority regulatory expectations)

• Support CMC and analytical manufacturing partners to develop & implement phase-appropriate qualification and re-qualification GxP standard as well as implementation for raw materials and consumables, and other CGT materials

• Proactively maintain Quality Assurance oversight for materials management, which may include support to vendor on onboarding, oversight of approved supplier lists, material qualification activities including method testing suitability, and the release and reconciliation/discard program.

• Responsible for the QA oversight of the raw material retain program, as well as stability program oversight, where applicable, to assure compliance with internal Vertex procedures and GxP regulatory standards.

• 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). Partner with stakeholders to mitigate the identified risks and implement associated actions throughout product life cycle.

• Serve as the Quality SME on Raw Material and Supply Chain/Logistics Governance teams, as applicable, covering Raw Material, associated Technical Operations, and Supply Chain topics for new material introductions, and vendor and process changes, across the product life cycle to assure a compliant materials management strategy is developed, executed and maintained.

• Chair/Lead in appropriate governance meetings for Quality members to critically review proposed complex changes, assure compliance to regulatory requirements, and drive standardized processes across sites.

• 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 in relation to raw material and consumable phase-appropriate qualification.

• Material release or disposition knowledge and experience for clinical or commercial manufacturing.

• 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.

• A minimum of 8 years leadership experience leading teams or directing allocation of resources is preferred.

• Previous experience within a leadership role for materials management is preferred.

• Bachelor's degree in a biotech/Lifesciences field, or relevant comparable background

• Master's or Advanced degree preferred.

Other Requirements:

• 5-15% travel required.

• This is an On-site designated role.

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.