Role: Director, Quality Assurance & Compliance
Location: Madison, WI (Onsite)
Compensation: $220,000 - $325,000 Total Compensation
About the Organization
Our client is a mission-driven, nonprofit biotechnology research organization focused on developing innovative therapies for serious mental health conditions. The organization is advancing novel treatment approaches through rigorous science, clinical development excellence, and a patient-centered philosophy.
As the company approaches a major regulatory milestone, it is building the quality and compliance infrastructure necessary to support commercialization and long-term success in an emerging therapeutic area.
Role Description
Our client is seeking a Director of Quality Assurance & Compliance to lead quality strategy during a critical phase of development. This individual will serve as the senior quality leader responsible for supporting an upcoming NDA submission and ensuring the highest standards of GxP compliance across clinical and development activities.
Key Responsibilities
- Lead Quality Assurance and Compliance activities supporting the organization's regulatory and development programs.
- Serve as the quality lead for an upcoming NDA submission and related approval activities.
- Own and maintain the Quality Management System (QMS) and associated quality processes.
- Provide strategic oversight of GxP compliance, including GMP and GCP activities.
- Drive inspection readiness initiatives and support interactions with regulatory agencies.
- Lead sponsor-side quality oversight of CROs, CMOs, laboratories, and other external partners.
- Support and manage regulatory inspections, audits, CAPAs, deviations, and quality risk management activities.
- Help define the future structure and growth of the Quality organization, including potential team leadership responsibilities.
Qualifications
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- 10+ years of progressive Quality Assurance experience within the pharmaceutical, biotechnology, or life sciences industry.
- Demonstrated experience leading quality activities for an NDA and/or BLA submission.
- Significant sponsor-side QA experience supporting drug development programs.
- Experience managing or supporting FDA inspections, including BIMO and/or Clinical Quality Assurance (CQA) inspections.
- Strong knowledge of GxP regulations, with experience in both GMP and GCP environments preferred.
This position requires full-time onsite presence in Madison, Wisconsin. Relocation assistance is available for qualified candidates.