GCP Operational Quality Associate Director

Vertex Pharmaceuticals • Boston, MA

21d • Hybrid

About The Position

The Biomarker Operational Quality Associate Director provides Biomarker quality leadership and oversight across GxP activities related to research and development, implementation into clinical trials, and potential commercialization of clinical biomarkers into IVDs. The role collaborates with business partners and GCP Operational Quality to drive quality outcomes and operational excellence, supporting operational management oversight and ensuring quality activities promote compliance, quality excellence, and readiness for future needs.

The Associate Director works with Biomarker Operations to develop meaningful quality indicators and metrics for ongoing evaluation of processes and quality-system health and identification of risks. Reporting directly to the Director, GCP Biomarker Operational Quality, the role works with other Quality members to support appropriate GxP compliance and consistent, fit-for-purpose quality oversight across programs and products.

The position also supports non-regulated research through staff training on applicable policies, guidance, and procedures, with emphasis on non-GxP functions that generate material for regulatory filings. It conducts Research QA reviews of non-GxP protocols and reports intended for regulatory submissions and supports communication, presentations, training, and complex project oversight. Vertex encourages continuous learning and thoughtful adoption of advances in AI, technology, automation, and industry trends to improve decision-making, innovation, efficiency, and patient outcomes.

Requirements

• Bachelor’s degree in a scientific or allied health field.
• Typically 10 years of experience or an equivalent combination of education and experience.
• Strong knowledge of data integrity principles and ALCOA.
• Broad knowledge of CLIA regulations (42 CFR Part 493), international equivalents, and applicable guidance such as ISO 15189:2022 and CLSI.
• Knowledge of in-vivo and/or in-vitro experimental design, planning, conduct, and reporting.
• Demonstrated experience interpreting and applying relevant GxP requirements, such as GLP and medical-device requirements, across products to drive phase-appropriate quality.
• Ability to collaborate effectively at all levels and drive delivery in a dynamic, fast-paced environment.
• Experience with quality metrics, dashboards, analysis, and improvement programs.
• Excellent oral and written communication skills and a proven record of influencing, building, and promoting a culture of quality and excellence.
• Strong problem-solving and critical-thinking skills to make sound decisions.
• Ability to work in a fast-paced environment and manage competing priorities.
• Ability to work independently and collaboratively; detail- and goal-oriented, with good judgment.

Responsibilities

• Partner with appropriate quality and compliance oversight of preclinical and clinical activities, including fit-for-purpose validations and associated processes, across modalities and in collaboration with Clinical Biomarkers and other stakeholders.
• Contribute to regulatory document reviews, including BBs, INDs, IDEs, and TMFs, identifying potential risks or gaps.
• Provide input into the development of requested and for-cause GCLP and GCP Biomarker vendor audit scope and focus.
• Support business initiatives involving processes, procedures, regulations, and tools intended to support non-clinical activities.
• Participate in strategic cross-functional initiatives to improve compliance with regulatory requirements, standards, and internal Vertex policies.
• Identify and anticipate potential compliance issues that could affect business goals, and develop and implement pragmatic, effective improvements and resolutions.
• Contribute to proactive reporting of significant quality issues related to Vertex preclinical product development, ensuring an aligned Quality point of view is represented.
• Contribute to inspection-readiness activities for product-development processes, including conducting requested inspection-readiness quality assessments of GLP/GCP Biomarker studies.
• Advise on audit strategy for GLP/GCP Biomarker vendors, processes, and systems.
• Engage with R&D vendor quality to provide input on vendor performance and risks.
• Contribute to governance meetings with business and Quality stakeholders, including agenda topics and meaningful metrics.
• Collaborate with Clinical and Preclinical stakeholders and Quality partners to design appropriate quality metrics for Biomarker activities.
• Communicate summary trends and insights on the quality of preclinical and clinical study delivery to relevant business and Quality partners and forums, such as Integrated Risk Teams.
• Participate in due diligence and integration activities as appropriate.
• Train research staff on applicable Vertex policies, guidance, and procedures, particularly for non-GxP research intended for regulatory filings.
• Conduct Research QA reviews of non-GxP protocols and reports intended for regulatory submissions to ensure clarity, consistency, and alignment with Vertex and regulator expectations.
• Communicate and, when necessary, escalate quality-assessment outcomes, including trends and action items, to meet Vertex Research needs.
• Assist with developing presentations and training.
• Assist with oversight and management of complex projects to ensure milestones are met.
• Collaborate with business stakeholders and Quality partners to develop meaningful quality metrics.

Benefits

• Annual bonus eligibility.
• Annual equity awards.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Other inclusive benefits and resources supporting employees’ career, financial, family, and wellbeing needs.

What This Job Offers

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