Director, Clinical Quality Program Lead (Hybrid)

Vertex Inc. • Boston, MA

1d • Hybrid

About The Position

The Director, Clinical Quality Program Lead (CQPL) is responsible for the quality oversight across a range of study phases within assigned disease area(s) to ensure that trials are conducted in accordance with GCP requirements. The CQPL has oversight of real-time inspection readiness, risk management and quality health of programs in their assigned disease area(s). This position reports directly to the Senior Director of Global Clinical Quality (GCQ) and will sit on the GCQ Leadership Team. This position will have line management responsibilities.

Requirements

• Typically requires 10+ years of relevant work experience, including experience in a GCP quality oversight role, or relevant comparable background
• Requires line management experience or other supervisory work
• Excellent understanding of ICH-GCP guidelines, and international clinical trial regulations (e.g., US Title 21 CFR, EU CTR, etc.)
• Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment
• Developing individuals and teams; proven leadership capabilities within multi-level organization
• Current knowledge of industry trends and best practices - for progressive quality risk management in a regulated environment
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
• Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality

Nice To Haves

• Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) is preferred
• Travel required up to 10% to vendors, investigator sites, etc.

Responsibilities

• Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness
• Proactively identifies risks to quality and assists with implementation of mitigations/contingency plans, providing regular updates to the R&D Quality Leadership Team and other cross-functional stakeholders at various levels
• Collaborates cross-functionally, to oversee and support the quality of all clinical trials within assigned disease areas, ensuring a focus on risk management and inspection readiness throughout
• Provides oversight to development, execution and continual improvement of quality risk management/mitigation and inspection readiness strategies across assigned disease areas in collaboration with cross-functional stakeholders in R&D Quality, Global Clinical Operations, etc.
• Provides leadership and guidance to implementation of risk-based approaches to quality for clinical development program(s) – e.g. Quality by Design principles, and ensure effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management
• Contributes to the strategic evolution of GCQ pillar, including development of key processes and departmental goals/objectives. Collaborates within RDQ to ensure a unified and effective risk & governance oversight models.
• Monitors quality and departmental metrics and identifies opportunities to optimize processes and procedures
• Responsible for people management including resource forecasting, hiring, training, employee goal setting, performance management, and career development. May also manage contract staff.
• Engages and provides consultation to business partners in advancing proactive and leading quality approaches incorporating best practices

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed