Associate director quality
The Role
We are seeking a highly motivated and experienced Associate Director to join Research & Development Quality with a focus on vendor quality. The role owns Quality Agreements (drafting through periodic review), manages vendor quality metrics and governance, and plans/leads risk‑based audits with durable CAPA follow‑through. The successful candidate will strengthen inspection readiness, harmonize processes and job aids, and enable data‑driven oversight of vendors in a fast‑moving environment. Here’s What You’ll Do- 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).
- 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).
- Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
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