GMP Quality & Compliance Lead — Audits & Systems

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

Benefits offered by this job

Hybrid work model

Competitive base salary

Medical, dental & vision insurance

401(k) plan with match

Employee Stock Purchase Plan

Paid time off & holidays

Job summary

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audit programs of CSPs and internal operations and ensure compliance with FDA, EU, ICH, and other international requirements.

The role oversees Quality Agreements and drives continuous improvement across GxP systems. This hybrid position is based in San Diego, CA or Princeton, NJ, requiring three days on-site. Ideal candidates have at least 6 years QA experience, including 3+ years GMP QA, with strong

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum of 6 years in QA with 3+ years direct GMP QA experience.
• Experience conducting external/internal GMP audits of CSPs and facilities.
• Working knowledge of FDA, EU/EudraLex and ICH GMP requirements.

Responsibilities

• Plan, schedule, coordinate and conduct GMP audits of CSPs, suppliers and internal operations.
• Prepare audit reports, evaluate observations and ensure corrective actions.
• Oversee Quality Agreements with clinical and commercial CSPs.
• Maintain internal audit program and compile metrics for management review.
• Develop and maintain SOPs; support continuous improvement of quality systems.
• Provide GxP compliance expertise across activities including recalls and QA systems.
• Ensure compliance with FDA, EU/EudraLex, Canadian and ICH GMP requirements.
• Provide CSV support for quality-system related computerized solutions.
• Recommend updates to quality policies based on evolving regulations.

Skills

GMP audits

Quality systems

GxP compliance

Regulatory affairs

Vendor management

Education

Bachelor’s degree in Life Sciences

Tools

CSV (Computer System Validation)

Quality Agreements

Job description

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audit programs of CSPs and internal operations and ensure compliance with FDA, EU, ICH, and other international requirements.

The role oversees Quality Agreements and drives continuous improvement across GxP systems. This hybrid position is based in San Diego, CA or Princeton, NJ, requiring three days on-site. Ideal candidates have at least 6 years QA experience, including 3+ years GMP QA, with strong