Associate Director, Quality Operations

Position Summary
The Associate Director, Quality Operations provides GMP quality oversight for internal operations and Contract Manufacturing Organizations (CMOs) across the product lifecycle, partnering with manufacturing and development teams to support reliable supply, regulatory compliance, and continuous improvement in line with FDA and global GMP requirements.

Primary Responsibilities
- Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products
- Manage batch review, disposition, and release for drug substance and drug product manufacturing and packaging
- Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs
- Serve as the primary quality interface with CMOs (SOPs, Quality Agreements, regulatory expectations)
- Lead investigations, change control, CAPA, and risk assessments related to GMP operations
- Support complaint handling (investigation and closure)
- Design, implement, and maintain Acadia’s GMP quality management system (US and international regulations)
- Provide on-site GMP support at CMOs (audits/inspections)
- Represent Quality Assurance on cross-functional GMP teams

Qualifications/Skills
- Bachelor’s degree in Chemistry, Biology, or related life science
- 8+ years pharmaceutical/biopharmaceutical experience
- 5+ years in Quality Assurance supporting GMP operations
- Experience with US FDA and international GMP regulations
- Experience overseeing CMOs and outsourced GMP manufacturing
- Travel: 15–20%

What we offer (US-based employees)
- Medical, dental, vision; employer-paid life, disability, business travel, EAP
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan (2-year lock-in)
- 15+ vacation days; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance