DLH Corporation · 1 day ago
Director, Quality Management Office (Job 1241) - Clinical, Biomedical, or Laboratory Research experience required
United States
Full-time
Remote
Director/Executive
$140K/yr - $160K/yr
12+ years expDLH Corporation delivers improved health and national security readiness solutions for federal programs through science research and development. The Director, Quality Management Office, provides strategic leadership to ensure quality and regulatory compliance across a diverse research enterprise, overseeing quality management and process optimization in clinical and biomedical research.
Computer Software
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 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
Qualification
Required
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 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
Preferred
Doctoral degree (PhD, PharmD, MD) in a relevant scientific, biomedical, or regulatory field
Certification such as RAC (Regulatory Affairs Certification), ASQ CQE/CQA, or equivalent
Experience with accreditation processes (e.g., CAP, CLIA) and international research standards
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
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, which includes a matching component
Training to help drive success
Access to our best-in-class e-learning suite for formal and informal learning
Professional and technical certification preparation
Education assistance at accredited institutions
Company
DLH Corporation
DLH solves health and national security challenges through digital transformation, science, research and development, and systems engineering.
1001-5000 employees
H1B Sponsorship
DLH Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageLeadership Team
Andy Clyde
CMOP Regional Manager
Ashley Blosser
GOVERNMENT CONTRACTOR / ACQUISITION LIFE CYCLE / LOGISTICIAN IV/ACQUISITION LEAD
Company data provided by crunchbase