Director, GCP Quality & Audit Excellence

Acadia Pharmaceuticals Inc.; San Diego (CA); Hybrid; USD 166,000 - 207,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

Paid vacation and holidays

Parental leave

Tuition assistance

Job summary

Acadia Pharmaceuticals Inc. is seeking a Director of GCP Quality Assurance to lead GCP audit activities across its clinical portfolio and ensure global regulatory compliance.

The role provides strategic oversight of quality systems, manages audit programs, and supports inspection readiness across FDA, ICH, and EU standards. The position requires a strong background in GCP, audits, and regulatory reporting, with proven experience leading cross-functional teams and improving quality processes.

Qualifications

• Bachelor’s degree in Life Sciences or related field or equivalent experience.
• 10+ years in pharmaceutical/biotech regulated industry.
• 5+ years as lead auditor for GCP audits.
• Knowledge of ICH-GCP, FDA, EU regulations and inspections.

Responsibilities

• Plan, conduct, and manage internal and external GCP audits of CSPs, CROs, and sites.
• Prepare and finalize audit reports with observations and corrective actions.
• Develop and maintain GCP Quality Agreements with partners.
• Maintain GCP audit metrics and quality reporting for management.
• Develop and maintain SOPs and quality documents for GCP activities.
• Support inspections and responses related to GCP studies.

Skills

Audit Management

GCP Compliance

Regulatory Knowledge

Lead Auditor

Quality Systems

Education

Bachelor’s in Life Sciences

Equivalent Experience

Tools

eCOA

CSV

QA Documentation

Job description

Acadia Pharmaceuticals Inc. is seeking a Director of GCP Quality Assurance to lead GCP audit activities across its clinical portfolio and ensure global regulatory compliance.

The role provides strategic oversight of quality systems, manages audit programs, and supports inspection readiness across FDA, ICH, and EU standards. The position requires a strong background in GCP, audits, and regulatory reporting, with proven experience leading cross-functional teams and improving quality processes.