Sr. Manager Quality Audit and Compliance

Acadia Pharmaceuticals Inc.•San Diego, CA

7d•Hybrid

About The Position

The Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations.

Requirements

Bachelor’s degree in a Life Sciences or related field. An equivalent combination of education and applicable job experience may be considered.
Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
Strong ability to interpret and apply U.S. and international cGMP requirements
Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
Ability to translate quality standards into practical implementation and review activities
Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
Strong collaboration skills with the ability to influence and gain cooperation across functions
Willingness to travel domestically and internationally (approximately 25–30%)

Nice To Haves

American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.

Responsibilities

Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
Other duties as assigned

Benefits

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