Director, GCP Quality Assurance

Role: Lead GCP Quality Assurance for clinical development, overseeing audits and compliance across Acadia’s portfolio of neurological and rare disease programs. Responsibilities: plan and execute internal and external GCP audits of CROs, investigator sites, and vendors; manage audit reports, quality agreements, and audit metrics; support inspection readiness, mock inspections, and regulatory interactions; provide GCP compliance guidance to stakeholders; develop and improve quality systems and SOPs. Requirements: Bachelor's in Life Sciences or related field; 10+ years in pharma/biotech; 5+ years of GCP QA and auditing experience; strong knowledge of ICH-GCP, FDA, EU regulations; experience auditing CROs and supporting regulatory inspections. Preferred: SQA, ASQ, Lead Auditor certifications; experience with global audits (US, EU, UK, Japan); familiarity with clinical service providers and systems such as eCOA and CSV. High-Value: Focus on GCP compliance in clinical trials, supporting late-stage programs in neuroscience; leads inspection readiness activities; manages external vendor audits. Work Setup: not specified, travel required for onsite and inspection activities.