Acadia Pharmaceuticals Inc. · 9 hours ago
Sr. Manager Quality Audit and Compliance
San Diego, CA
Full-time
Hybrid
Senior Level
$148K/yr - $184K/yr
6+ years expAcadia Pharmaceuticals is committed to transforming scientific promise into innovative solutions for underserved neurological and rare disease communities. The Senior Manager of Quality Audit and Compliance will lead and execute internal and external audits, ensuring compliance with GMP and GxP regulations while optimizing the Quality Management System across clinical and commercial operations.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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%)
Preferred
American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus
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
Company
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals develops and commercializes small molecule drugs for the treatment of central nervous system disorders.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$811.73MKey Investors
National Institute of Neurological Disorders and StrokeOxford Bioscience PartnersNational Institute of Mental Health
2019-09-17Post Ipo Equity· $287.5M
2018-11-30Post Ipo Equity· $316.25M
2013-01-02Post Ipo Equity· $86.39M
Leadership Team
Catherine Adams
Chief Executive Officer
Steve Davis
President and CEO
Recent News
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