Senior QA Compliance Manager — Hybrid GMP Audit Leader

acadiapharmaceuticals; Princeton (NJ); Hybrid; USD 138.000 - 172.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) Plan with a fully vested match

Employee Stock Purchase Plan

Vacation and holidays

Tuition assistance

Zusammenfassung

Acadia Pharmaceuticals in the United States is seeking a Sr. Manager, Quality Assurance Compliance to lead internal and external GMP audit activities and maintain robust quality systems across CSPs and operations.

You will ensure compliance with FDA, EU/EudraLex, ICH and other GMP requirements, oversee Quality Agreements, and drive continuous improvement of GxP processes and documented systems. The role is hybrid with three onsite days weekly and may be based in San Diego, CA or Princeton, NJ

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• Minimum of 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP QA experience.
• Experience conducting external/supplier and internal GMP audits.
• Working knowledge of U.S. and international GMP regulations (FDA, EU/EudraLex, ICH).
• Experience applying GMP requirements across pharma operations including clinical development, manufacturing, technology transfer, and/or commercial activities.

Aufgaben

• Plan, schedule, coordinate, and conduct GMP compliance audits of CSPs, suppliers, and internal operations.
• Prepare and review audit reports, evaluate observations and corrective actions.
• Oversee the development, approval, and maintenance of Quality Agreements with CSPs.
• Maintain the internal audit program and compile audit metrics.
• Prepare, review, and maintain SOPs and support continuous improvement of quality systems.
• Provide compliance expertise across GxP activities and required recall/alert processes.
• Ensure quality systems comply with FDA, EU/EudraLex, ICH, and other GMP requirements.
• Provide CSV support for quality system-related computerized solutions.
• Recommend and implement updates to quality policies and procedures.

Kenntnisse

GMP audits

Quality Assurance

Regulatory compliance

CSV

Ausbildung

Bachelor's degree in Life Sciences or related field

Tools

Quality systems

Computer System Validation (CSV)

Jobbeschreibung

Acadia Pharmaceuticals in the United States is seeking a Sr. Manager, Quality Assurance Compliance to lead internal and external GMP audit activities and maintain robust quality systems across CSPs and operations.

You will ensure compliance with FDA, EU/EudraLex, ICH and other GMP requirements, oversee Quality Agreements, and drive continuous improvement of GxP processes and documented systems. The role is hybrid with three onsite days weekly and may be based in San Diego, CA or Princeton, NJ