Senior QA Audit & Compliance Leader

Acadia Pharmaceuticals; San Diego (CA); Hybride; USD 138 000 - 172 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

Medical, dental, and vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Sick time

Parental leave

Tuition assistance

Résumé du poste

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Assurance Compliance to lead GMP audit activities and maintain robust quality systems across CSPs and internal operations. The role ensures compliance with U.S. and international GMP requirements while supporting Quality Agreements and CSV initiatives.

This is a hybrid role based in either San Diego, CA or Princeton, NJ, with travel as needed and potential for equity-based rewards. A strong background in GMP and regulatory affairs is essential.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum 6 years of quality assurance experience, including at least 3 years in GMP QA.
• Experience conducting external/supplier and internal GMP audits.
• Knowledge of US and international GMP regulations (FDA, EU/EudraLex, ICH).
• Experience applying GMP requirements across pharma/biopharma ops including clinical development, manufacturing, tech transfer, or commercial.

Responsabilités

• Plan, schedule, and conduct GMP audits of CSPs, suppliers, and internal ops.
• 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 and trends.
• Prepare, review, and maintain SOPs and drive quality system improvements.
• Provide compliance expertise across GxP activities including product reviews and recalls.
• Ensure quality systems comply with FDA, EU/EudraLex, ICH and other GMP requirements.
• Provide CSV support for quality-system related computerized solutions.
• Update quality policies and procedures based on regulatory changes.
• Perform other duties as assigned.

Connaissances

GMP audits

Quality Systems

Regulatory compliance

CSV support

FDA/ICH knowledge

Formation

Bachelor’s degree in Life Sciences or related field

Description du poste

Acadia Pharmaceuticals seeks a Sr. Manager, Quality Assurance Compliance to lead GMP audit activities and maintain robust quality systems across CSPs and internal operations. The role ensures compliance with U.S. and international GMP requirements while supporting Quality Agreements and CSV initiatives.

This is a hybrid role based in either San Diego, CA or Princeton, NJ, with travel as needed and potential for equity-based rewards. A strong background in GMP and regulatory affairs is essential.