GMP Quality Assurance & Compliance Leader

Regulatory Jobs; Princeton (NJ); Hybrid; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Employee stock purchase plan

Vacation + holidays

Paid leave

Tuition assistance

Job summary

Acadia Pharmaceuticals is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal ops, ensure regulatory alignment, and oversee quality systems. You will drive continuous improvement across GxP operations, maintain Quality Agreements, and provide compliance expertise across FDA, EU/EudraLex, and ICH standards.

The role supports US-based operations in a hybrid setup (Princeton or San Diego) with a competitive base salary, bonus eligibility, and equity options.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 6 years of progressively responsible QA experience, incl. 3 years GMP QA.
• Experience conducting external/internal GMP audits and supplier audits.

Responsibilities

• Plan, schedule, and conduct GMP audits of CSPs, suppliers, and internal ops.
• Prepare and review audit reports, evaluate observations and corrective actions.
• Oversee Quality Agreements with clinical and commercial CSPs.
• Maintain internal audit program and compile audit metrics/trends.
• Prepare and maintain SOPs aligned with GMP requirements.

Skills

GMP audits

Quality Assurance

Regulatory compliance

GxP knowledge

FDA/EU/ICH knowledge

Education

Bachelor's degree Life Sciences

6+ years QA experience

3+ years GMP QA

Job description

Acadia Pharmaceuticals is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal ops, ensure regulatory alignment, and oversee quality systems. You will drive continuous improvement across GxP operations, maintain Quality Agreements, and provide compliance expertise across FDA, EU/EudraLex, and ICH standards.

The role supports US-based operations in a hybrid setup (Princeton or San Diego) with a competitive base salary, bonus eligibility, and equity options.