Senior Manager, Clinical Study Quality Lead (Hybrid)

General Summary The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This individual‑contributor role focuses on GCP quality assurance oversight for clinical trials, including risk‑based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. This position is on‑site or hybrid and is not eligible for a fully remote work arrangement. Key Duties and Responsibilities Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance to clinical study teams and key stakeholders. Partner cross‑functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and maintain inspection readiness. Conduct risk‑based quality reviews of protocols, informed consent documents, and other key study documentation to identify potential compliance and operational risks. Advise clinical study teams on quality risks and support the development of practical, risk‑based mitigation strategies. Develop and oversee investigator site audit plans for assigned studies, ensuring alignment with study risk, audit strategy, and company expectations. Lead and/or support domestic and international investigator site audits and inspection readiness activities. Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed, addressed, and resolved in a timely manner. Support quality issue investigations, including root cause analysis, CAPA planning, and follow‑up of effectiveness measures. Review and monitor clinical quality data, compliance signals, and study‑level trends, escalating significant risks or concerns as appropriate. Contribute to ongoing process improvement and continuous quality initiatives to strengthen GCP compliance across clinical programs. Support regulatory agency inspections at Vertex and/or clinical investigator sites, as needed. May contribute to the review of SOPs, work instructions, and internal guidance documents that support the clinical quality management system. Required Experience Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience providing oversight for clinical trials, or equivalent combination of education and experience. Candidates must have direct, hands‑on experience providing GCP QA oversight for clinical trials. Experience supporting clinical study quality in a sponsor, CRO, or similarly regulated clinical research environment. Experience supporting clinical development programs for drugs and biologics. Required Knowledge and Skills Strong knowledge of ICH GCP E6(R3) and applicable global clinical trial regulations and guidance. Demonstrated experience in GCP clinical trial quality oversight, including audit support, inspection readiness, quality issue management, root cause analysis, and CAPA. Ability to identify GCP compliance risks, assess impact, and apply risk‑based quality principles in a clinical trial environment. Strong communication skills, with the ability to work effectively across internal and external stakeholders. Ability to work independently, manage multiple priorities, and deliver high‑quality work in a fast‑paced environment. Strong organizational, project management, and problem‑solving skills. Preferred Skills Experience supporting devices, combination products, or cell and gene therapy clinical trials. Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit is highly desirable. Professional certification such as RQAP‑GCP, CCRP, or similar. Other Requirements Up to 10% travel may be required. Pay Range $137,800 – $206,800 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 Hybrid: work remotely up to two days per week; or select On‑Site: work five days per week on‑site with ad hoc flexibility. 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 View email address on click.appcast.io #J-18808-Ljbffr Vertex Pharmaceuticals