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:

$188,000 - $282,000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear:

to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.