Director, Quality Management Office – Clinical, Biomedical, Laboratory Research
DLH Corporation
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $140,000 - $160,000 per year
Job Level
About the role
- Provide enterprise-wide leadership and oversight for multi-disciplinary quality and regulatory teams.
- Direct the development, implementation, and continual improvement of the Quality Management Plan and related Standard Operating Procedures.
- Ensure compliance with applicable federal and international regulations.
- Oversee the implementation and enforcement of biosafety management systems.
- Develop and execute comprehensive audit and inspection programs.
- Recruit, mentor, and develop quality assurance and regulatory staff.
Requirements
- 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 in quality and regulatory management 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.
- Proven record of successful audit/inspection readiness and compliance.
- Strong professional, scientific, and technical writing skills.
- Exceptional leadership, analytical, and cross-functional collaboration skills; proficiency with electronic quality, document, and biospecimen/data management systems.
Benefits
- Personal Time Off (PTO)
- Medical, dental, vision insurance
- Supplemental life with AD&D
- Short and long-term disability
- Flexible spending accounts
- Parental leave
- Legal services
- 401(k) Retirement Plan with matching component
- Training and education assistance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementregulatory oversightaudit programsinspection programsbiosafety management systemscompliancequality assuranceclinical trialstechnical writingdata management
Soft skills
leadershipmentoringanalytical skillscross-functional collaboration