Sr. Manager Quality Audit and Compliance
Acadia Pharmaceuticals Inc.
Summary
The Sr. Manager, Quality Assurance Compliance will play a key role in supporting Acadia's growing portfolio by leading internal and external GMP audit activities and maintaining robust quality systems. This position is responsible for ensuring Contract Service Providers (CSPs) and internal operations meet Acadia standards and applicable U.S. and international regulatory requirements, while overseeing Quality Agreements and supporting continuous improvement across GxP operations.
Job description
Position Summary
The Sr. Manager, Quality Assurance Compliance will play a key role in supporting Acadia's growing portfolio by leading internal and external GMP audit activities and maintaining robust quality systems. This position is responsible for ensuring Contract Service Providers (CSPs) and internal operations meet Acadia standards and applicable U.S. and international regulatory requirements, while overseeing Quality Agreements and supporting continuous improvement across GxP operations.
Primary Responsibilities
- Plan, schedule, coordinate, and conduct GMP compliance audits of Contract Service Providers (CSPs), suppliers, and internal operations in accordance with company standards and applicable domestic and international regulations
- Prepare and review audit reports, evaluate observations and corrective actions, and ensure identified compliance issues are appropriately addressed
- Oversee the development, negotiation, approval, and maintenance of Quality Agreements with clinical and commercial CSPs
- Maintain the internal audit program and compile audit metrics and compliance trends to support Management Review and quality system oversight
- Prepare, review, and maintain Standard Operating Procedures (SOPs) and support continuous improvement of quality systems in accordance with current GMP requirements and industry standards
- Provide compliance expertise across GxP activities, including annual product reviews, mock recalls, field alerts, actual recalls, and quality system-related computerized solutions
- Ensure quality systems, procedures, and processes comply with applicable FDA, EU/EudraLex, Canadian, ICH, and other international GMP requirements
- Provide Computer System Validation (CSV) support for quality system-related computerized solutions, as needed
- Recommend and implement updates to quality policies and procedures based on evolving regulations, compliance trends, and business requirements
- Perform other duties as assigned
Education and Experience
- Bachelor's degree in Life Sciences or a related field, or an equivalent combination of relevant education and experience
- Minimum of 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP Quality Assurance experience
- Experience conducting external/supplier and internal GMP audits, including audits or inspections of manufacturing facilities
- Working knowledge of U.S. and international GMP regulations and quality requirements, including applicable FDA, EU/EudraLex, and ICH requirements
- Experience applying GMP requirements across relevant pharmaceutical or biopharmaceutical operations, including clinical development, manufacturing, technology transfer, and/or commercial activities
Requirements
- Bachelor's degree in Life Sciences or a related field, or equivalent combination of relevant education and experience
- Minimum of 6 years of progressively responsible Quality Assurance experience
- At least 3 years of direct GMP Quality Assurance experience
- Experience conducting external/supplier and internal GMP audits, including audits or inspections of manufacturing facilities
- Working knowledge of U.S. and international GMP regulations, including FDA, EU/EudraLex, and ICH requirements
- Experience applying GMP requirements across pharmaceutical or biopharmaceutical operations, including clinical development, manufacturing, technology transfer, and/or commercial activities
Benefits
- Medical, Dental & Vision
- Employer-Paid Life Insurance
- Disability Coverage
- Business Travel Coverage
- Employee Assistance Program
- 401(k) Matching
- Employee Stock Purchase Plan
- 15+ Vacation Days
- 13-15 Paid Holidays
- 10 Days Paid Sick Time
- Paid Parental Leave
- Tuition Assistance
- Bonus
- Equity Awards
Company overview
Acadia Pharmaceuticals Inc. is a biopharmaceutical company headquartered in San Diego, California, founded in 1993. The company specializes in developing and commercializing innovative therapies for underserved neurological disorders and rare diseases. Acadia has pioneered the first and only FDA-approved treatments for Parkinson's disease psychosis (NUPLAZID®) and Rett syndrome (DAYBUE®). With a workforce of 501-1,000 employees, the company maintains a robust pipeline focused on addressing unmet medical needs in Alzheimer's disease psychosis, Lewy body dementia psychosis, Prader-Willi syndrome, and other central nervous system disorders. Acadia operates with a mission to transform scientific promise into meaningful innovations that improve patient lives, particularly in neurological and rare disease communities where treatment options are limited. The company is publicly traded on NASDAQ under the symbol ACAD and has established itself as a leader in neuroscience therapeutics through its commitment to research, development, and patient-centered care.