Director, Product Quality - Biologics & Device (Hybrid)

Director, Product Quality

The Director, Product Quality for the Biologics and Device Quality organization is accountable for end-to-end quality oversight of Biologics and Combination Device program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle management activities. This oversight includes setting and maintaining overall Quality strategies in support of commercialization efforts including establishing relevant product quality standards for current or novel technologies ensuring QA and cross-functional alignment with industry and regulatory expectations, identifying product quality risks and mitigations throughout the development lifecycle of the assigned program, through commercialization and decommissioning. The candidate should have a good understanding of Biologics and Combination Device drug development and commercialization and be able to partner effectively with development functions (i.e., process development, analytical development, manufacturing science and technology, site QA / QC, and regulatory CMC and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain, Distribution Quality, RA) to enable a robust product development (Quality by Design - QbD) approach that considers technical, regulatory, and quality / compliance considerations per cGMP regulation. The candidate will ensure a robust supply chain and support product launch activities per program needs.

The candidate will foster strong collaboration and partnership with external and internal stakeholders, and the international Quality leadership team. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices to facilitate maximum value to evaluation of the health of the quality system.

Key Duties & Responsibilities

• Provide clearly defined Quality expectations, Quality strategy, and Quality deliverables for the assigned program(s) within the Vertex product portfolio, including in-licensed and outsourced products, as part of commercialization and product lifecycle management.
• Develop, approve, and maintain critical Quality standards and control requirements for products and processes (e.g., stage gate deliverables, product specifications, stability program development), working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle and QbD. Ensure quality and compliance frameworks, guidance, and systems are in place to keep them current with general industry and health authority expectations as well as Vertex's QMS.
• Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with development 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 internal Vertex standards, integrating the scientific intent of the technical SMEs and clinical phase-appropriate approaches, as applicable.
• Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing and across all drug product presentations in support of commercialization. Ensure that the identified risks, mitigations, and possible improvements are understood by CMC development team stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission, and launch.
• During lifecycle management of a product, support post-approval changes due to continuous improvement, regulatory requirements or commitments, geo-expansion strategy, and business driven reasons. Proactively identify Quality risks and product quality issues and support post-approval changes to mitigate these risks by partnering with the commercial manufacturing project teams and stakeholders.
• Ensure significant Quality risks are escalated per the company procedure and properly mitigated in a timely manner by working with the cross-functional / site teams.
• Champion a consistent approach to Quality and compliance standards as they relate to product, recognizing the wider implications of Quality-related issues, including the implementation of the principles of Quality by Design and new and emerging regulatory guidance.
• May serve as a single point of Quality contact for new product introduction and PAI readiness for the assigned product(s) on the CMC product and / or project governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP / GDP clinical trial materials and commercial products to ensure a global Quality strategy is developed and maintained for consistency and standardization (to the extent it is practical).
• Represent Quality at appropriate governance meetings to critically review product strategy, promoting a risk-based approach.
• Act as a project manager within Quality for the assigned project, ensuring and facilitating effective multi-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.
• Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving relevant documents per team timeline and associated HA questions 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.
• Define resource allocation for network of QA resource assignment for his / her / their assigned products.

and Experience

Required Knowledge / Skills