R&D Quality Assurance Leader

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

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.