Associate Director, R&D Quality — Vendor Quality & Audits

BioSpace; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Access to fitness and mental health support

Generous paid time off

Family planning and adoption benefits

Job summary

A leading biotech company in Massachusetts is seeking an experienced Associate Director, R&D Quality. This role manages vendor quality, oversees audits, and drafts Quality Agreements. The ideal candidate should have over 8 years in R&D Quality, strong knowledge of compliance standards, and excellent stakeholder management skills. The position offers a comprehensive benefits package and a collaborative work environment.

Qualifications

• 8+ years of experience in R&D Quality, Quality Assurance, or related discipline within the pharmaceutical/biotech industry.
• Proven track record drafting and negotiating Quality Agreements.
• Strong working knowledge of ICH E6 (R2/R3), GCP/GLP/GCLP.

Responsibilities

• Own the lifecycle of Quality Agreements.
• Establish and maintain a vendor quality metrics framework.
• Lead and oversee risk-based vendor audits.

Skills

R&D Quality

Quality Assurance

Stakeholder management

GxP audits

Vendor oversight

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva QMS/QualityDocs

eTMF

reporting/visualization tools

Job description

A leading biotech company in Massachusetts is seeking an experienced Associate Director, R&D Quality. This role manages vendor quality, oversees audits, and drafts Quality Agreements. The ideal candidate should have over 8 years in R&D Quality, strong knowledge of compliance standards, and excellent stakeholder management skills. The position offers a comprehensive benefits package and a collaborative work environment.