Sr. Manager Quality Audit and Compliance

Acadia Pharmaceuticals • Princeton, NJ

6d • 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%)
• Manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals.
• It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends.
• Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
• This 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level