GMP Quality & Compliance Senior Manager

Acadia Pharmaceuticals Inc.; San Diego (CA); Hybrid; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Plan with company match 1:1 up 

Employee Stock Purchase Plan

15+ vacation days

Paid holidays (13–15)

Job summary

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal operations, maintain robust quality systems, and ensure adherence to FDA, EU/EudraLex, ICH, and other global requirements.

The role supports QA programs, quality agreements, and continuous improvement across GxP operations. Hybrid onsite work in San Diego, CA or Princeton, NJ with base compensation and potential bonuses.

Qualifications

• Bachelor’s degree in Life Sciences or a related field.
• 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.

Responsibilities

• Plan, schedule, coordinate, and conduct GMP compliance audits of 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

Skills

GxP compliance

Audits (GMP)

Quality systems

CSV support

Regulatory knowledge (FDA/EU/ICH)

Education

Bachelor’s degree in Life Sciences

Equivalent combination of education and experience

Job description

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal operations, maintain robust quality systems, and ensure adherence to FDA, EU/EudraLex, ICH, and other global requirements.

The role supports QA programs, quality agreements, and continuous improvement across GxP operations. Hybrid onsite work in San Diego, CA or Princeton, NJ with base compensation and potential bonuses.