Applied Research and Analysis Company (ARAC) · 5 days ago
Regulatory Specialist & Quality Management Systems Manager
Greater Richmond Region
Full-time
Onsite
Senior Level
5+ years expApplied Research and Analysis Company (ARAC) is a recognized leader in behavioral science research, providing scientifically sound and customizable studies. They are seeking a meticulous and strategically minded QMS & Quality Control Manager who will be responsible for developing and overseeing the Quality Management System, ensuring compliance with regulatory standards, and leading quality control efforts throughout the research process.
Research
Responsibilities
Maintain and oversee a robust QMS specifically designed for the PMTA pathway, ensuring scalability and compliance with ISO 9001 or 13485 standards where applicable
Draft, review, and manage all Standard Operating Procedures (SOPs) and Quality Manuals
Lead the CAPA program (Corrective and Preventive Actions) to identify systemic issues and implement sustainable solutions
Audit trial Master Files (TMF) and study documentation for accuracy, completeness, and "ALCOA+" (Attributable, Legible, Contemporaneous, Original, Accurate) principles
Oversee data management and ethical research standards for behavioral surveys, pharmacokinetic (PK) studies, and actual use research
Conduct external audits of clinical sites and laboratory facilities to ensure readiness for FDA inspections
Act as the primary point of contact for quality-related inquiries during FDA inspections
Proactively monitor evolving ethical research guidelines and regulatory guidance to maintain compliance
Develop and deliver training programs for staff on GCP, GLP, and internal quality standards
Manage the vendor qualification process , auditing and validating external partners to ensure they meet our quality benchmarks
Qualification
Required
Bachelor's degree in a scientific, healthcare, or regulatory discipline
5+ years in Quality Assurance/Quality Control within a clinical research environment (CRO or Pharma)
Deep expertise in FDA 21 CFR Part 11
Excellent verbal and written communication skills
Commitment to maintaining the highest standards of integrity and professional ethics
Preferred
Master's or PhD
CQA (Certified Quality Auditor) or similar
Prior experience in the behavioral science, medical device, or healthcare regulatory field
Company
Applied Research and Analysis Company (ARAC)
Applied Research and Analysis Company (ARAC) is a leading U.S.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase