Director, Clinical Quality Program Lead (Hybrid)

Job Description

General/Position Summary

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.

Key Duties & 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

Required Experience

• 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

Required Knowledge/Skills

• 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

Other Requirements

• Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) is preferred

• Travel required up to 10% to vendors, investigator sites, etc.

#LI-hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com