Associate Director, R&D Quality

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

Join to apply for the Associate Director, R&D Quality role at BioSpace

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.

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).

Benefits

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

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.