Sr. Manager, Clinical GCP Quality

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced clinical quality professional to provide oversight and leadership in GCP quality management, audit execution, inspection readiness, and continuous improvement for clinical development programs. This role ensures compliance with global regulatory standards and supports quality initiatives across clinical trials and vendor partnerships.

Responsibilities:

• Lead and enhance the Quality Management System, managing quality events such as deviations, CAPAs, and change controls, and ensuring alignment with global GCP and regulatory standards.
• Drive inspection readiness activities, including participation in mock and actual inspections, and support the development of regulatory responses and CAPA commitments.
• Plan, conduct, and manage audits of investigator sites, CROs, vendors, and clinical systems, ensuring timely follow-up and verification of CAPA effectiveness.
• Oversee vendor qualification and ongoing compliance, partnering with business functions to assess and monitor outsourced activities and ensure regulatory requirements are met.
• Provide proactive quality oversight throughout the clinical trial lifecycle, supporting risk-based quality management and collaborating with study teams to mitigate compliance risks.
• Ensure inspection-ready trial master files and data integrity across clinical systems, supporting TMF quality reviews and addressing quality events involving eTMF, EDC, IRT, and safety databases.
• Author, review, and revise SOPs and operational procedures, leading process improvement initiatives to enhance efficiency and maintain compliance.
• Deliver quality training programs, mentor operational teams on inspection readiness, and promote a culture of quality, transparency, and continuous improvement across R&D functions.

Qualifications:

• Bachelor's degree in Life Sciences or related discipline required; advanced degree preferred.
• 8+ years of experience in biotech or pharmaceutical industry, with a strong record in R&D QA.
• Comprehensive knowledge of FDA, ICH, and EMEA guidelines and regulations.
• Demonstrated leadership and collaboration skills within cross-functional project teams.
• Excellent time management, prioritization, and multitasking abilities to meet critical deadlines.
• Strong oral and written communication skills, with the ability to present information clearly and logically.
• Proven ability to anticipate and address issues, with strong attention to detail and problem-solving skills.
• Experience with quality event management (CAPAs, change controls, deviations), TMF oversight, and use of systems such as Veeva.
• International study experience and CRO-side quality experience are highly valued.
• Proficient in Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
• Strong commitment to ethical standards and ability to work effectively in a team environment.

Published Category: Quality & Validation