Product Quality Director – CMC Small Molecule QA

Product Quality Director – CMC Small Molecule QA

Requirements

• Bachelor’s or Master’s degree in a Scientific/Technical/Business discipline.
• Minimum of 10 years of deep and broad experience in a technical, quality, and/or regulatory role within the pharmaceutical/biopharmaceutical industry in product development and associated project management and governance is required.
• Expertise in cGMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance, quality standards, policies and procedures.
• Demonstrated application of the principles of cGMP and Quality Assurance.
• Experience in the practicalities of implementing 21st century cGMP guidelines, ICH Q8/9/10/11, PAT/ASTM guidance, etc.
• In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies.
• Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member.
• Demonstrated influential leadership experienced in operating in a matrix organization (across boundaries) with Technical, Supply Chain and Regulatory functional areas through presenting, influencing, negotiation and partnering is required.
• Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
• Experience in technology transfer, process development and/or process validation.

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.
• 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.

Preferred Qualifications

• Key areas of preferred expertise are: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring.
• A minimum of 5 years in directly managing staff and/or leadership experience in leading cross-functional teams, projects, programs, or directing allocation of resources is preferred.
• Previous experience on a Site Leadership Team or R&D Leadership Team is strongly preferred.