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).

Here’s What You’ll Bring to the Table: 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).

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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