Associate Director, Product Quality
About the role
For our client, we are seeking an Associate Director, Product Quality to join the team of a leader in the Pharmaceuticals & Biotech space. This role will oversee product quality strategy and execution across development-stage programs, with a strong focus on GxP compliance and outsourced manufacturing partners. The Associate Director will help build scalable quality systems, guide release readiness, and support regulatory-facing activities that are critical to advancing products through the development lifecycle. This position will also partner closely with internal teams and external vendors to strengthen quality oversight, inspection preparedness, and overall product integrity.
Location: Remote - US based candidates only, no visa sponsorship available. Compensation: $117,000 – $189,200 annually.
Responsibilities
- Design, implement, and scale a Quality Management System (QMS) for the development stage
- Provide GxP compliance oversight for internal functions and outsourced partners, ensuring robust supplier management
- Lead quality function activities, including deviations, CAPAs, change control, and document control
- Serve as quality lead for regulatory submissions and clinical trial material release
- Drive quality input for tech transfers, CMC activities, and scale-up plans
- Oversee batch record review and product release processes
- Prepare the organization for regulatory inspections and audits, serving as a primary quality representative
Qualifications
- BS or higher in Life Sciences, Chemistry, Pharmacy, or a related field
- 8+ years of experience in pharmaceutical quality roles, including 3+ years in a leadership position
- Experience with document control software such as ZenQMS, Veeva Vault, or MasterControl
- Strong knowledge of GxP regulations, including FDA, EMA, and ICH guidance, and quality best practices across the product lifecycle
- Familiarity with multiple dosage forms and CDMO-based manufacturing
Benefits
- Eligibility to participate in a company-sponsored 401(k) and pension plan
- Vacation benefits and flexible spending accounts for healthcare and dependent care
- Comprehensive medical, dental, vision, and prescription drug benefits
- Life insurance and death benefits
- Well-being benefits including employee assistance programs and fitness benefits