QA & Compliance Leader: GMP Audits & Quality Systems

Acadia Pharmaceuticals

Princeton (NJ)

Hybrid

USD 138,000 - 172,000

Full time

5 hours ago
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Benefits offered by this job

Medical, dental, and vision insurance
401(k) Plan with company match
Employee Stock Purchase Plan
Vacation days (15+) and paid holidays
Paid sick time
Paid parental leave
Tuition assistance

Job summary

Acadia Pharmaceuticals is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal operations, ensuring compliance with FDA, EU/EudraLex, ICH, and other international GMP requirements. You will oversee quality systems, QA processes, and quality agreements across GxP activities.

The role requires a minimum of 6 years in QA, a Life Sciences degree, and ability to travel. Hybrid role; three onsite days weekly in Princeton or San Diego, with competitive salary and

Qualifications

  • GMP audits of CSPs and internal operations
  • Maintain quality systems across GxP
  • Regulatory compliance with FDA/EU/ICH
  • Develop and review Quality Agreements
  • Provide CSV support when needed

Responsibilities

  • Plan, schedule, and conduct GMP audits of CSPs and internal ops
  • Review audit reports and corrective actions
  • Maintain Quality Agreements with CSPs
  • Manage internal audit program and metrics
  • Prepare SOPs and drive quality system improvements
  • Support FDA/EU/ICH regulatory compliance

Skills

GMP audits
Quality systems
CSV support
Quality Agreements
Regulatory knowledge
SOPs management

Education

Bachelor’s degree in Life Sciences

Job description

Acadia Pharmaceuticals is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audits of CSPs and internal operations, ensuring compliance with FDA, EU/EudraLex, ICH, and other international GMP requirements. You will oversee quality systems, QA processes, and quality agreements across GxP activities.

The role requires a minimum of 6 years in QA, a Life Sciences degree, and ability to travel. Hybrid role; three onsite days weekly in Princeton or San Diego, with competitive salary and

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