Senior Manager, Clinical Study Quality Lead (Hybrid)

Regulatory Toolkit; Boston (MA); Hybrid; USD 138,000 - 207,000; Full time

Benefits offered by this job

Hybrid-Eligible

Job summary

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to oversee GCP QA for assigned trials, collaborating with study teams, CROs, vendors and sites to ensure compliance with ICH GCP and global regulations. This on-site or hybrid role supports inspection readiness and quality improvements across Vertex clinical programs.

The ideal candidate has 6+ years of hands-on GCP QA experience in sponsor/CRO settings and a strong background in drugs/biologics development, with a Bachelor’s

Qualifications

• Bachelor’s degree required with 6+ years of direct GCP QA experience.
• Hands-on GCP QA oversight for clinical trials in sponsor/CRO settings.
• Experience supporting clinical development programs for drugs/biologics.

Responsibilities

• Provide study-level GCP QA oversight for assigned trials and guide study teams.
• Partner with CROs, vendors and sites to support quality oversight and inspection readiness.
• Conduct risk-based quality reviews of protocols and key documents to identify compliance risks.
• Advise on quality risks and develop practical mitigation strategies.
• Develop and oversee site audit plans and ensure alignment with study risk and company expectations.
• Lead or support domestic and international investigator site audits and inspections.
• Review audit reports and CAPA plans to ensure timely resolution of findings.
• Support quality issue investigations including root cause analysis and CAPA follow-up.
• Monitor quality data and study trends, escalate significant risks as needed.
• Contribute to process improvements and GCP compliance initiatives.

Skills

GCP QA oversight

Audit planning

Quality risk assessment

Communication

Project management

Inspection readiness

Education

Bachelor’s degree

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.

#LI-Hybrid

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision‑making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

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
• 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 [e-mail]