Hybrid Senior QA & Compliance Lead — GMP & CSP Audits

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Hybrid; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan with company match

Equity awards

Paid time off

Job summary

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audit activities for CSPs and internal operations while upholding global regulatory standards.

You will manage Quality Agreements, drive continuous improvement across GxP systems, and provide expert QA compliance guidance for FDA, EU, ICH, and other requirements. A hybrid work setup is available from Princeton or San Diego.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent experience.
• Minimum 6 years in Quality Assurance with at least 3 years GMP QA.
• Experience conducting external/internal GMP audits of facilities.

Responsibilities

• Plan, schedule, and conduct GMP audits of CSPs, suppliers, and internal ops.
• Prepare audit reports, evaluate observations, and track corrective actions.
• Maintain Quality Agreements with CSPs and internal teams.
• Oversee internal audit program and compile metrics for reviews.
• Draft and maintain SOPs; support continuous improvement of quality systems.
• Provide QA compliance expertise across GxP activities and recalls as needed.
• Ensure compliance with FDA, EU/EudraLex, ICH, and other GMP requirements.
• Provide CSV support for quality system software as needed.

Skills

GMP audits

Quality Systems

Audit management

Regulatory compliance

CSV support

Education

Bachelor's degree in Life Sciences

Tools

Audit management software

CSV tools

Job description

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audit activities for CSPs and internal operations while upholding global regulatory standards.

You will manage Quality Agreements, drive continuous improvement across GxP systems, and provide expert QA compliance guidance for FDA, EU, ICH, and other requirements. A hybrid work setup is available from Princeton or San Diego.