Associate Director, Quality Operations

Position Summary

Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products.

Primary Responsibilities

• 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 Requirements

• Regular standing, walking, sitting, and the use of hands for handling or operating equipment
• 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
• Lift and/or move up to 20 pounds occasionally
• Ability to travel independently overnight and/or work after hours as required by travel schedules or business needs

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

EEO Statement (US-based Employees)

We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way.

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Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia

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