Quality Assurance, Director at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Assurance, Director in the United States.

This role provides strategic and operational leadership for enterprise-wide quality and regulatory compliance across complex research programs. As the Director of Quality Management, you will oversee multi-disciplinary teams, ensuring that clinical trials, laboratory research, and epidemiological studies meet the highest standards of scientific rigor, safety, and regulatory alignment. You will drive process optimization, risk management, and continuous improvement initiatives while maintaining strong relationships with internal leadership, regulatory bodies, and external stakeholders. The position blends hands-on oversight with strategic vision, guiding teams through audits, inspections, and quality program development. You will play a key role in professional writing, proposal development, and business development support. This is a high-impact role where your expertise directly influences research excellence, compliance, and organizational success.

• Provide enterprise-wide leadership for quality and regulatory teams supporting multi-site clinical trials, laboratory biospecimen processing, and survey-based research
• Direct the development, implementation, and continual improvement of the Quality Management Plan (QMP) and Standard Operating Procedures (SOPs), integrating risk-based management practices and internal controls
• Ensure compliance with federal (FDA, NIH, CDC), international (ICH GCP, GLP, ISO), biosafety (BSL-2), human subject protection (HHS/OHRP, IRB), and privacy (HIPAA) regulations
• Oversee audit readiness, inspection programs, and CAPA processes while engaging with sponsors, regulatory agencies, and external assessors
• Recruit, mentor, and develop high-performing QA and regulatory teams to sustain operational excellence in complex research environments
• Serve as the principal subject matter expert on quality and regulatory affairs, representing the organization with regulatory bodies, sponsors, clients, and accrediting agencies
• Contribute to professional writing, technical proposals, statements of work, and responses to RFPs/RFIs to support business development initiatives

• Bachelor’s or Master’s degree in biomedical science, public health, laboratory science, clinical research, or a related field
• 12+ years of experience with a Master’s degree or 14+ years with a Bachelor’s degree in progressive quality and regulatory management roles, including 6+ years in leadership
• Advanced expertise in quality assurance and regulatory oversight for multi-site clinical trials and laboratory research
• Strong knowledge of federal, international, and sponsor regulations, including FDA, 21 CFR, ICH GCP, GLP, BSL-2, CLIA, ISO, OHRP, HIPAA, and IRB/ethics
• Proven audit and inspection readiness experience with documented success in compliance and remediation efforts
• Exceptional leadership, cross-functional collaboration, and analytical skills, with proficiency in electronic quality, document, and biospecimen/data management systems
• Strong professional and technical writing skills, including proposals, RFPs, SOPs, and quality documentation
• Preferred: Doctoral degree (PhD, PharmD, MD), RAC or ASQ CQE/CQA certifications, experience with accreditation processes, and familiarity with FDA regulatory pathways

• Competitive base salary with performance incentives
• Comprehensive medical, dental, and vision coverage, plus supplemental life, AD&D, and short/long-term disability insurance
• Flexible spending accounts and parental leave programs
• Generous Paid Time Off (PTO) and 401(k) Retirement Plan with matching contributions
• Career development opportunities, including training, e-learning, professional certification preparation, and tuition assistance
• Supportive and collaborative environment focused on continuous improvement and research excellence