GCP Operational Quality Senior Manager

Vertex is seeking a Senior GCP Operational Quality Manager to conduct quality assurance oversight and management activities for clinical trial operations, ensuring compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, and Vertex policies and procedures.

Responsibilities

• Serve as the Quality Lead for assigned clinical programs, providing GCP compliance interpretation, consultation, and support to maintain and improve the quality of Vertex research, ensuring protection of subjects' safety, rights, and well-being, as well as data integrity.
• Maintain contemporary knowledge of industry trends, standards, and methodologies related to GCP.
• Liaise with Vertex clinical functions and external parties (CROs, vendors, investigator sites) to promote high-quality standards and consistency across programs.
• Provide QA review of protocols and participate in Operational Review Boards to identify operational risks and collaborate on risk mitigation strategies.
• Develop risk-based audit plans for assigned programs, ensure audits are conducted per plan, review audit reports, and evaluate responses and CAPA plans in line with company standards.
• Manage and/or lead domestic and international audits for Clinical Investigators to ensure compliance with ICH GCP, regulations, and company standards.
• Lead quality issue investigations, root cause analysis, and CAPA development for assigned programs/studies, assisting teams in implementing corrective and preventive actions.
• Contribute to continuous quality improvement initiatives.
• Engage with study teams for proactive inspection readiness across assigned programs.
• Provide inspection support for Regulatory Agency inspections at Vertex facilities or Clinical Investigator sites.
• Serve as a GCP Quality Management System representative, as needed.
• Participate in collaborative reviews of impacted SOPs and work instructions.
• Review and analyze key performance indicator data and trends, proposing remedial or preventive actions.
• Participate in process improvement initiatives.
• Develop and maintain QA relationships with GCP vendors to conform to quality agreements and participate in Vendor Joint Operating Committees, as needed.

Requirements

• In-depth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations, MHRA Statutory Instruments).
• Strong experience with all phases of clinical trial development involving drugs, biologics, devices, and drug/device combinations.
• In-depth knowledge of Event Management processes, including investigation, root cause analysis, CAPA plan development, and effectiveness checks.
• Ability to understand and translate customer needs, bringing innovative perspectives to quality management solutions.
• Professional, clear, and concise communication skills, both verbal and written, for internal and external stakeholders.
• Ability to work independently with minimal guidance, organizing and prioritizing work effectively.
• Proficiency in managing complex projects, meeting goals and deadlines.
• Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio).
• Up to 10% travel may be required.

Qualifications

• Bachelor’s degree in a scientific or allied health discipline.
• Typically requires 6 years of experience or an equivalent combination of education and experience.

Pay

The pay range for this role is $137,800 - $206,800. This range reflects the base salary and does not include annual bonus, equity awards, or overtime pay (where applicable). Actual base salary will be determined by factors such as skills, competencies, and experience.

Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a Hybrid-Eligible role, allowing you to choose between:

• Hybrid: Work remotely up to two days per week.
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: Flex status is subject to Vertex’s Policy on Flex @ Vertex Program and may change.