QA Manager/GCP Auditor

ROLE OBJECTIVESPartner with the Senior Director of QA to maintain and enhance the Quality Management System, including oversight of the electronic QMS platform.Author SOPs related to GCP QA and review or approve SOPs from other functions as needed.Review and/or approve key clinical trial documents and support eTMF compliance activities.Conduct clinical site audits; develop audit agendas, reports, and follow-up actions.Provide input for risk management activities and documentation related to clinical trials.Qualify clinical vendors and establish Quality Agreements.Advise on clinical Notes to File, deviation reports, and CAPAs.Support development of the Quality Plan and annual Quality Objectives.Contribute to materials and presentations for Quality Management Review Meetings.Assist in hosting regulatory inspections, including FDA Pre-Approval Inspections.Collaborate cross-functionally to ensure ongoing compliance with applicable regulations.Deliver GCP training to internal teams and partners.Support Regulatory Affairs by providing QA input for submissions and responses to health authority inquiries.Maintain current knowledge of industry practices and evolving regulatory expectations related to GCP and clinical trial execution.EDUCATION & EXPERIENCE REQUIREMENTSBachelor’s degree in a life sciences discipline.Minimum of 10 years of experience in Clinical Quality Assurance within a sponsor, CRO, investigator site, or regulatory agency.Strong working knowledge of GCPs (ICH, FDA, EMA) and related guidance documents, including those addressing computerized systems used in clinical trials.Deep understanding of Phase 1–3 clinical trial requirements.Experience with clinical trial risk management methodologies.Experience contributing to or supporting regulatory submissions (e.g., IND, NDA, BLA).Experience hosting FDA Pre-Approval Inspections is highly desirable.CORE COMPETENCIESProficiency with Microsoft Office Suite.Excellent written and verbal communication skills.Ability to work independently while managing multiple complex projects.Demonstrated discretion in handling confidential information.Strong follow-up, follow-through, and accountability.Exceptional organizational, multitasking, and time-management skills.High attention to detail and strong problem-solving ability.Comfortable working with minimal supervision in a fast-paced environment.