Director, GCP Quality Assurance

The role

The Director, GCP Quality Assurance leads Good Clinical Practice audit activities across the clinical development portfolio. This role provides strategic oversight of GCP quality systems and manages audit programs to ensure compliance with global regulatory requirements.

What you will do

• Plan, schedule, conduct, and manage internal and external GCP audits of CSPs, CROs, investigator sites, and supporting vendors
• Prepare, review, and finalize audit reports and track corrective actions
• Lead the development, review, and maintenance of GCP Quality Agreements
• Maintain GCP audit metrics and deliver quality and compliance reporting
• Develop, review, and maintain SOPs and quality documents
• Manage the internal GCP audit program including planning, execution, and follow-up
• Support mock inspections, regulatory inspections, and responses
• Provide GCP compliance guidance and oversight to cross-functional stakeholders
• Recommend and implement improvements to GCP quality systems and processes

Required qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline, or an equivalent combination of education and relevant experience
• 10+ years of experience within the pharmaceutical, biotechnology, or related regulated industry
• 5+ years of direct experience in GCP Quality Assurance, compliance, and auditing functions
• Demonstrated experience serving as a Lead Auditor for internal and external GCP audits
• Strong knowledge of ICH-GCP guidelines and applicable FDA, EU, and international GCP regulations
• Experience auditing CROs, investigator sites, vendors, and other GCP service providers
• Experience supporting regulatory inspections and inspection readiness activities
• Ability to interpret and apply global GCP regulations to quality systems and clinical trial operations
• Ability to stand, walk, sit, use hands, reach, climb, balance, stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations
• Ability to occasionally lift and/or move up to 15 pounds
• Ability to travel independently overnight and work after hours if required

Nice to have

• SQA, ASQ, or Lead Auditor certification
• Experience conducting global audits across US, EU, UK, Japan, and other international regions
• Experience with clinical service providers and supporting functions such as eCOA, computerized system validation (CSV), and data management

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

About the company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.