Associate Director, R&D Quality

Role Summary

Associate Director, R&D Quality with a focus on vendor quality. Own Quality Agreements, manage vendor quality metrics and governance, and plan/lead risk-based audits with durable CAPA follow-through. Strengthen inspection readiness, harmonize processes and job aids, and enable data-driven oversight of vendors in a fast-moving environment.

Responsibilities

• Own the lifecycle of Quality Agreements (scope, drafting/redlining, execution, periodic review, and change control).
• Establish and maintain a vendor quality metrics framework, dashboards, and governance cadence; trend and escalate risks.
• Lead and/or oversee risk-based vendor audits (GCP/GLP/GCLP as applicable); plan, conduct, report, and verify CAPA effectiveness.
• Partner with stakeholders to prioritize and qualify/approve vendors.
• Lead or contribute to cross-functional teams with Procurement and Legal to align MSAs/SOWs with Quality Agreements.
• Author or update SOPs, work instructions, and job aids to harmonize vendor quality processes across RDQ&C.
• Utilize quality systems (e.g., Veeva QMS/QualityDocs, eTMF, issue/deviation management) to manage agreements, audit records, and performance.
• Provide training and coaching to study and functional teams on vendor quality obligations and audit/inspection behaviors.
• Collaborate cross-functionally to enhance vendor oversight practices and foster continuous improvement.
• Ability to travel 10–30% (domestic and international).

Qualifications

• Bachelor’s degree in life sciences or related field required.
• 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 with Legal/Procurement and external partners.
• Demonstrated experience planning/leading GxP audits and driving effective CAPAs to closure.
• Strong working knowledge of ICH E6 (R2/R3), GCP/GLP/GCLP, data integrity principles, and 21 CFR Part 11/EU Annex 11.
• Comfort with quality systems and metrics (e.g., Veeva, reporting/visualization tools); concise, executive-ready communication.
• Excellent stakeholder management and influence skills; ability to operate in a fast-paced, high-growth environment.
• Preferred: vendor oversight across clinical and nonclinical domains (e.g., CROs, central/specialty labs, eClinical/data platforms).

Education