Job Description

General/Position Summary

• The Senior Director, Quality is responsible for the oversight of Product Quality Leads for all Vertex Small Molecule programs, development and commercial. As the group leader, the Sr. Director is responsible for supporting commercialization, filing/approval, launch, and post approval lifecycle management. This role will partner closely with Quality and business stakeholders to ensure identification and mitigations of risks, alignment with regulatory and commercial strategy supported by development. The Sr. Director will also participate in/lead Small Molecule program Quality governance committees and is accountable for ensuring timely program stage review and specification review boards. This position will be based in Vertex's corporate headquarters in Boston, MA.
• This is a hybrid role working 3 days on-site and up to two days remotely.

Key Duties & Responsibilities

• Drive Quality expectations and strategy guidance, collaborate with peer Quality leaders to ensure completion of deliverables for all programs within the small molecule portfolio, including in-licensed and outsourced products, as part of product lifecycle management.
• Lead critical evaluation of new products and processes with respect to Quality and compliance requirements. Work with CMC functions and supply chain to improve manufacturing processes, new product introduction standards, and overall program strategy and keep them current with global regulatory expectations and Vertex QMS standards, integrating the scientific intent of the technical SMEs and clinical phase-appropriate approaches, as applicable.
• Lead PQLs to proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing and all drug product presentations in support of commercialization. Drive process ensuring identified Quality risks, mitigations, and possible improvements are understood by CMC team stakeholders. PQLs to collaborate with project teams and stakeholders to establish risk mitigations for development, validation, submission, and launch, as necessary.
• Drive Quality expectations to include Quality leaders and relevant business leaders in program governance committees (stage review, specification review board, etc.) for endorsement. Continue to enhance and evolve governance committees.
• Support preparation of CMC investigational and commercial regulatory submissions by critically reviewing and approving relevant documents per program timeline and associated HA information requests on the filing. Support device development for combination products (as needed) by taking part in design history file reviews, strategy, risk identification, and risk mitigation.
• Provide significant CDMO-focused regulatory filing input (IND, NDA, BLA, etc.) and ensure product-focused pre-approval inspection and commercial readiness activities at the CDMOs in collaboration with Inspection Management and Compliance teams. Adjudicate on compliance discussions and negotiate any required corrective actions.
• Lead appropriate governance meeting topics for Quality members to critically review proposed complex changes (e.g., multi-product or multi-site), promoting a risk-based approach to change control. Ensure/facilitate effective bi-directional communication between the Quality groups and cross-functional teams and ensuring standardized processes (e.g., new product introduction, risk assessments, technology transfers, etc.) are used across sites.
• Represent Quality in program discussions and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities and talent building

Education and Experience

• Bachelor's and Master's degree in a Scientific/Technical/Business discipline.
• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Experience as a Product Quality Lead for a product/program that has advanced from development into commercial.
• Successful people development and leader experience.
• In-depth global health regulatory agency knowledge and experience across GxP life cycle in small molecules, devices and combination products preferred.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in across product modalities, different types of process, fill/finish and testing.
• Current knowledge of industry trends and best practices.
• Excellent communication skills 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.
• Critical Thinking and Problem-Solving skills.

Other Requirements

• 15% travel
• Hybrid role in Boston, MA

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND2

Company Information