Associate Director Quality Assurance

POSITION SUMMARY: The Associate Director, Clinical Quality Assurance will be responsible for providing Quality Assurance (QA) support to the organization’s Clinical Operations and Medical Affairs functions. This role involves reviewing and approving clinical trial documentation, authoring and maintaining relevant Standard Operating Procedures (SOPs), and conducting clinical site audits. The ideal candidate will possess a strong background in Phase 1–3 clinical trials, Quality Assurance, and Good Clinical Practice (GCP) regulations in both the United States and the European Union.ABOUT THE ORGANIZATION: This is a remote-based, globally operating organization experiencing rapid growth and expansion. This dynamic environment offers numerous opportunities for career advancement and professional development. The team works across multiple time zones and collaborates with a variety of internal and external partners. The company culture emphasizes discipline, high performance, results orientation, and excellence in execution. The mission centers on advancing mental healthcare through the development of innovative, next-generation therapeutics.OBJECTIVES:Collaborate with the Senior Director, QA, to maintain the Quality Management System, including oversight of the electronic QMS (eQMS) tool.Author, review, and approve SOPs related to GCP QA; contribute to the development of other SOPs as needed.Review and/or approve clinical trial documentation to ensure compliance with applicable regulations and maintenance of the electronic Trial Master File (eTMF).Conduct audits of clinical trial sites, including developing audit agendas and reports.Provide input on risk management documentation and activities associated with clinical trials.Qualify clinical vendors and establish Quality Agreements.Offer guidance on clinical Notes to File, deviation reports, and Corrective and Preventive Actions (CAPAs).Contribute to the Quality Plan, Quality Objectives, and Quality Management Review Meetings.Support FDA inspections, including Pre-Approval Inspections.Collaborate with cross-functional teams to ensure compliance with applicable regulations.Deliver GCP training to relevant stakeholders.Partner with Regulatory Affairs to provide documentation for submissions and respond to health authority inquiries.Maintain current knowledge of industry standards, best practices, and regulatory guidelines related to GCP and clinical trials.EDUCATION AND EXPERIENCE:Bachelor’s degree in Life Sciences or a related field.Minimum of ten (10) years of experience in Clinical Quality Assurance within a sponsor, Contract Research Organization (CRO), investigator site, or regulatory agency environment.Strong working knowledge of GCPs (ICH, FDA, EMA) and applicable guidance documents (e.g., computerized systems used in clinical trials).Familiarity with requirements for Phase 1–3 clinical trials and associated risk management practices.Experience supporting regulatory submissions (e.g., IND, NDA, BLA).Proven experience in hosting or supporting FDA Pre-Approval Inspections.