Senior Manager, Clinical Study Quality Lead

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 138,000 - 207,000; Full time

Job summary

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level GCP quality oversight for assigned trials. You will partner with clinical study teams, CROs, vendors, and investigator sites to ensure compliance with ICH GCP E6(R3) and global regulations, and support inspection readiness.

The role requires a Bachelor’s degree and 6+ years of direct GCP QA experience in a sponsor or CRO setting.

Qualifications

• Bachelor’s degree and 6+ years of direct GCP QA experience.
• Hands-on GCP QA oversight for clinical trials in sponsor or CRO environments.
• Experience supporting clinical development programs for drugs/biologics.
• Strong knowledge of ICH GCP E6(R3) and global trial regulations.

Responsibilities

• Provide study-level GCP QA oversight for assigned trials.
• Partner with CROs, vendors, and sites to ensure inspection readiness.
• Conduct risk-based quality reviews of key study documents.
• Advise on risk-based mitigation strategies and CAPA planning.
• Develop investigator site audit plans and support audits/inspections.
• Monitor quality data and study-level trends; escalate risks as needed.

Skills

GCP QA oversight

Audit planning

CAPA planning

Risk-based quality

Inspection readiness

Cross-functional partnership

Quality data monitoring

Education

Bachelor’s degree

6+ years GCP QA experience

Job description

Job Description 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 is an individual contributor role focused 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. The ideal candidate brings direct, hands-on GCP QA experience supporting clinical trials in a sponsor, CRO, or similarly regulated clinical research environment. 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 the 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/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:

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:

In this Hybrid-Eligible role, you can choose to be designated as:

1. Hybrid: work remotely up to two days per week.
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 [e-mail].

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 and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters 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 16 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 LinkedIn, Facebook, Instagram, YouTube, and X. We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.