Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Associate Director, Quality Operations plays a critical role in ensuring the quality, compliance, and integrity of Acadia's clinical and commercial products. This role provides GMP quality oversight for both internal operations and Contract Manufacturing Organizations (CMOs) across all stages of the product lifecycle. The position partners closely with manufacturing and development teams to support reliable supply, regulatory compliance, and continuous improvement in alignment 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 activities 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 to ensure compliance with SOPs, Quality Agreements, and regulatory expectations
- Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations
- Support complaint handling activities, including investigation and closure
- Support the design, implementation, and maintenance of Acadia's GMP quality management system in compliance with US and international regulations
- Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required
- Represent Quality Assurance on cross-functional GMP manufacturing, packaging, supply chain, and development teams
- Other duties as assigned
Education/Experience/Skills- Bachelor's degree in Chemistry, Biology, or a related life science
- Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
- Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
- Demonstrated experience with US FDA and international GMP regulations
- Experience overseeing CMOs and outsourced GMP manufacturing activities
- Ability to travel up to 15-20%
Physical RequirementsThis role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$145,100-$181,400 USD
What we offer US-based Employees:- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
