Associate Director, GLP/GCP Quality Audits and Compliance

Acadia Pharmaceuticals Inc.•San Diego, CA

1d•Hybrid

About The Position

The Associate Director, GLP/GCP Quality Audits and Compliance plays a critical role in protecting data integrity and regulatory readiness across the company’s nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of internal and external GLP/GCP audits, ensuring compliance with U.S. and international regulations while driving continuous improvement in quality systems. As a trusted quality partner, this role provides expert guidance on GLP/GCP compliance, supports regulatory inspections, and works closely with internal teams and Contract Service Providers (CSPs) to maintain inspection-ready operations. The ideal candidate brings strong audit leadership, sound regulatory judgment, and the confidence to influence quality practices across the organization.

Requirements

Bachelor’s degree in Life Sciences or a related scientific/technical discipline. An equivalent combination of education and applicable job experience may be considered
Targeting 8+ years of progressively responsible experience within quality assurance (QA), including 5+ years directly responsible for GLP/GCP QA, with direct experience leading external and internal audits
Extensive knowledge of guidelines and international regulations that affect the GLP/GCP QA programs
Thorough knowledge of quality management best practices within the pharmaceutical, biopharmaceutical, or other regulated industries
Demonstrated expertise in quality assurance activities and ICH, FDA, EU, and international GLP/GCP regulations as they apply to nonclinical and clinical studies
Proven ability to interpret and apply GLP/GCP regulations, including U.S. and global requirements
Hands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilities
Strong capability to translate quality standards into practical implementation, assess compliance, and drive continuous process improvement
Effective communicator able to present technical and regulatory information clearly across functions and to different stakeholder groups
Ability to create alignment and shared understanding among peers and stakeholders, effectively coordinating resources and motivating teams to achieve quality objectives
Demonstrated analytical, planning, and negotiation skills, with sound judgment in evaluating risk and compliance impact
Collaborative approach with a proven ability to gain cooperation and influence outcomes without direct authority
Willingness to travel domestically and internationally (approximately 25–30%)

Nice To Haves

Society for Quality Assurance (SQA), American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus

Responsibilities

Plan, schedule, coordinate, and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs) in accordance with company standards and global regulatory requirements
Own the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actions
Prepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved
Develop, review, and maintain GLP/GCP quality agreements, SOPs, and related quality documentation supporting nonclinical and clinical activities
Maintain, manage, and continuously improve the internal GLP/GCP audit program, ensuring ongoing inspection readiness
Compile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspections
Serve as a GLP/GCP subject matter expert, partnering with internal and external stakeholders (e.g., laboratory leadership, study directors, regulatory affairs, CSPs) to ensure consistent regulatory compliance
Support internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide impact, and ensure adherence to company policies, including Privacy/HIPAA and other applicable legal and regulatory requirements
Other duties as assigned

Benefits

Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance