Quality and Compliance Specialist
Listed on 2026-10-24
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Direct Hire Quality and Compliance Specialist
Position SummaryWe are seeking a Quality & Compliance Specialist to support clinical trial quality, regulatory compliance, and inspection readiness. This hands‑on role will develop standard operating procedures (SOPs), establish practical quality processes, conduct audits, and drive corrective and preventive actions.
The ideal candidate brings strong clinical quality assurance experience, works independently, and partners effectively with clinical teams to support Good Clinical Practice (GCP), data integrity, and continuous improvement.
Key ResponsibilitiesAuthor and implement SOPs, work instructions, and quality processes, including developing new procedures where none exist.
Monitor day-to-day GCP compliance across active clinical studies.
Conduct internal audits of Trial Master Files (TMFs), site files, and vendor documentation; identify gaps and ensure timely resolution.
Investigate audit findings, prepare responses, develop corrective and preventive action (CAPA) plans, and verify their effectiveness.
Lead inspection‑readiness activities and serve as a key contact during health authority inspections and sponsor audits.
Apply an understanding of clinical site and CRO operations to support quality oversight, including decentralized trial models and vendor activities.
Partner with clinical teams to implement clear, practical processes that support compliant study execution.
Review quality‑critical study documents, including protocols, informed consent forms, and monitoring plans.
Track quality metrics and key performance indicators (KPIs), report trends to leadership, and recommend improvements.
Develop and deliver GCP and compliance training for staff and site personnel.
Serve as a resource for data integrity practices and the application of ALCOA+ principles.
Minimum QualificationsBachelor’s degree in life sciences, health sciences, or a related field.
Four to seven years of experience in clinical quality assurance or GCP compliance, including direct responsibility for audits and quality documentation.
Strong working knowledge of ICH‑GCP guidelines and applicable FDA regulations, including 21 CFR Parts 11, 50, 54, 56, and 312.
Demonstrated ability to independently author SOPs and develop and implement quality processes.
Experience with CAPA systems, TMF management, and preparing audit findings and responses.
Ability to work independently, prioritize competing responsibilities, and take ownership of quality initiatives within a lean team.
Strong written communication, analytical, and collaborative problem‑solving skills.
Preferred QualificationsExperience with decentralized clinical trials and vendor or CRO oversight.
Experience leading or hosting health authority inspections.
Experience in a small biotechnology company or CRO, with responsibilities spanning multiple quality functions.
Schedule & TravelFull‑time, hybrid position based in the Washington, DC metro area.
Onsite attendance required for audits and team meetings.
Occasional travel for site visits or sponsor audits, as needed.
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