Sr Manager, Clinical Quality

ClinLab Solutions Group; Waltham (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

ClinLab Solutions Group in Waltham, MA is seeking a Sr. Manager, R&D Quality to lead QA oversight for GCP, GLP, and GVP compliance across the clinical development lifecycle.

The role requires strong leadership to manage audits, CAPAs, and risk assessments, while guiding inspection readiness and regulatory responses. Office-based role with three in-office days per week, reporting to the Director of R&D Quality.

Qualifications

• Bachelor's degree in Life Sciences or related discipline; advanced degree a plus.
• 8+ years of biotech/pharmaceutical QA experience.
• Thorough understanding of FDA, ICH and EMEA guidelines.
• Strong leadership and time management with cross-functional collaboration.
• Excellent verbal and written communication skills.

Responsibilities

• Quality Management System (QMS) oversight and maintenance.
• Manage quality events including Deviations, CAPAs, Change controls, and Risk assessments.
• Perform trend analyses and report quality metrics to senior leadership.
• Ensure processes comply with FDA, ICH, EMEA and GxP standards.
• Lead audit programs including investigator site, CRO, and vendor audits.
• Support regulatory responses and remediation efforts.
• Oversee TMF and data integrity in clinical systems.
• Deliver training across R&D functions.
• Promote a culture of quality and inspection readiness.

Skills

Leadership

Cross-functional collaboration

Communication

Project management

Audit management

Education

Bachelor's degree in Life Sciences

Advanced degree

Tools

Microsoft Office

SharePoint

Excel

PowerPoint

Job description

Reporting to the Director, R&D Quality, the Sr. Manager, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GCP, GLP, and/or GVP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, and providing training.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities

• Quality Management System (QMS)
• Support the maintenance and continuous improvement of the Quality Management System
• Manage quality events including Deviations, CAPAs, Quality issues, Change controls, and Risk assessments
• Perform trend analysis and communicate quality metrics to senior leadership
• Ensure quality processes remain aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standards
• Inspection Readiness and Regulatory Support
• Participate in inspection readiness activities across clinical development functions
• Support development and review of regulatory responses, CAPA commitments, and root cause analyses
• Participate in the conduct of mock and actual inspections
• Audit Program Management
• Plan, conduct, and manage investigator site audits, CRO audits, vendor audits, system and process audits, pharmacovigilance audits (as applicable)
• Review audit reports and assess findings for risk and regulatory significance
• Monitor audit observations through completion and CAPA effectiveness verification
• Partner with business functions to assess and monitor outsourced activities
• Evaluate vendor quality systems and qualification packages
• Support vendor selection, qualification, and ongoing oversight
• Ensure vendor compliance with contractual and regulatory requirements
• Clinical Trial Quality Oversight
• Provide proactive quality oversight throughout the clinical trial lifecycle
• Support implementation of critical-to-quality factors and Risk-Based Quality Management (RBQM) strategies
• Collaborate with study teams to identify and mitigate compliance risks and ensure appropriate escalation pathways
• TMF and Data Integrity Oversight
• Partner with functional teams to ensure inspection-ready trial master files
• Support TMF quality reviews and remediation efforts
• Assess data integrity controls across clinical systems and processes
• Review quality events involving: eTMF systems, EDC systems, IRT platforms, safety databases, laboratory vendors
• SOP and Process Improvement
• Author, review, and revise quality and operational procedures
• Ensure procedures remain compliant and inspection-defensible
• Lead process improvement initiatives that enhance efficiency while maintaining compliance
• Training and Quality Culture
• Deliver quality training programs across R&D functions
• Mentor operational teams on inspection readiness and compliance expectations
• Promote a culture of quality, transparency, and continuous improvement
• Serve as a trusted advisor to functional leadership

Qualifications

• Requires a Bachelor's degree in Life Sciences or related discipline (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience
• Clear record of success in R&D QA in the biotech/pharmaceutical industry
• Thorough understanding of FDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Demonstrated leadership and collaboration skills in a cross-functional project team
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint, etc.)