[Hiring] Quality Assurance Director @DLH

Role Description

The Director, Quality Management Organization (QMO), provides visionary strategic, operational, and technical leadership to ensure the highest standards of quality and regulatory compliance across a diverse research enterprise. This critical role commands a broad span of control, overseeing quality and regulatory systems for an active public health and scientific research organization encompassing complex, multi-site clinical trials, clinical, observational, and epidemiological research. The Director manages all aspects of quality management, process optimization, regulatory alignment, professional writing, proposal development, business development activities, and continuous improvement to support organizational goals, compliance obligations, and research excellence.

Responsibilities

• Provide enterprise-wide leadership and oversight for multi-disciplinary quality and regulatory teams supporting clinical trials, epidemiological research, BSL-2 laboratory biospecimen processing, and survey-based projects.
• Direct the development, implementation, and continual improvement of the Quality Management Plan (QMP) and related Standard Operating Procedures (SOPs), ensuring integration of risk-based quality management practices and robust internal controls across all research activities.
• Ensure strict compliance and alignment with all applicable federal (FDA, NIH, CDC), international (ICH GCP, GLP, ISO), regulatory, contractual, biosafety (including BSL-2), human subject protection (HHS/OHRP, IRB), and privacy (HIPAA) requirements.
• Oversee the implementation and enforcement of biosafety management systems and maintain the integrity and inspection readiness of all regulatory and quality documentation, including electronic systems and Trial Master Files.
• Develop and execute comprehensive audit and inspection programs, manage CAPA processes, and directly engage with sponsors, regulatory agencies, and external assessors, leading remediation and continuous improvement efforts.
• Recruit, mentor, and professionally develop quality assurance, quality improvement, and regulatory staff to sustain high-performing, cross-functional teams suited for high-complexity research environments.
• Serve as the organization’s principal subject matter expert and liaison on quality and regulatory affairs, engaging with regulatory bodies, sponsors, clients, IRBs, accrediting agencies, and internal leadership.
• Lead and contribute to professional writing, technical proposal development, statements of work, and responses to RFPs/RFIs, supporting business development activities and showcasing organizational quality and regulatory capabilities.

Qualifications

• Bachelor's or Master’s degree in biomedical science, public health, laboratory science, clinical research, quality/regulatory discipline, or a related field.
• At least 12 years of experience with a Master's degree OR 14 years of experience with a Bachelor's degree of progressive quality and regulatory management experience in clinical, biomedical, or laboratory research organizations, including 6 years in a leadership or director-level role.
• Demonstrated expertise in quality assurance and regulatory oversight of multi-site clinical trials, with advanced knowledge of federal, international, and sponsor regulations (e.g., FDA, 21 CFR, ICH GCP, GLP, BSL-2, CLIA, ISO, OHRP, HIPAA, IRB/ethics).
• Proven record of successful audit/inspection readiness and compliance, including substantial experience planning for, managing, and hosting sponsor, client, and regulatory audits, as well as developing and managing QMPs and SOPs in complex research environments.
• Strong professional, scientific, and technical writing skills, including the development of quality and regulatory content for proposals, RFPs, and business development.
• Exceptional leadership, analytical, and cross-functional collaboration skills; proficiency with electronic quality, document, and biospecimen/data management systems; and outstanding communication with regulatory authorities, sponsors, and multidisciplinary research teams.

Requirements

• Preferred - Doctoral degree (PhD, PharmD, MD) in a relevant scientific, biomedical, or regulatory field.
• Preferred - Certification such as RAC (Regulatory Affairs Certification), ASQ CQE/CQA, or equivalent.
• Preferred - Experience with accreditation processes (e.g., CAP, CLIA) and international research standards.
• Preferred - Demonstrated knowledge of FDA regulatory process and landscape, including familiarity with key regulatory pathways (e.g., IND, NDA, BLA, 510(k), PMA) and documentation requirements.
• Preferred - Experience interpreting and applying current FDA regulations, guidance documents, and best practices throughout the product development lifecycle is highly desirable.

Benefits

• Personal Time Off (PTO)
• Medical, dental, vision, supplemental life with AD&D
• Short and long-term disability
• Flexible spending accounts
• Parental leave
• Legal services
• 401(k) Retirement Plan with matching component
• Access to best-in-class e-learning suite for formal and informal learning
• Professional and technical certification preparation
• Education assistance at accredited institutions