Provide enterprise-wide leadership and oversight for multi-disciplinary quality and regulatory teams supporting clinical trials and research projects.
Direct the development, implementation, and continual improvement of the Quality Management Plan (QMP) and Standard Operating Procedures (SOPs).
Ensure compliance with federal, international, and sponsor regulations, and oversee implementation of biosafety management systems.
Develop and execute audit and inspection programs and engage with sponsors and regulatory agencies for continuous improvement.
Recruit and mentor quality assurance staff and serve as the principal subject matter expert on quality and regulatory affairs.
Lead professional writing, technical proposals, and responses to business development inquiries.

Requirements

Bachelor's or Master’s degree in biomedical science, public health, laboratory science, clinical research, or a related field.
At least 12 years of experience with a Master's degree OR 14 years 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, with 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, with experience in planning, managing audits and developing QMPs and SOPs in complex environments.
Strong professional, scientific, and technical writing skills, including developing regulatory content for proposals and business development.
Exceptional leadership, analytical skills, and proficiency in electronic quality management systems; outstanding communication with regulatory bodies and multidisciplinary teams.
Preferred - Doctoral degree (PhD, PharmD, MD) in a relevant field.
Preferred - Certification such as RAC, ASQ CQE/CQA, or equivalent.
Preferred - Experience with accreditation processes (e.g., CAP, CLIA).

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
training for career development
e-learning suite access for formal and informal learning
professional and technical certification preparation
education assistance at accredited institutions

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality assuranceregulatory oversightaudit readinesscompliance managementQuality Management Plan (QMP)Standard Operating Procedures (SOPs)technical writingregulatory content developmentaccreditation processesbiosafety management systems

Soft Skills

leadershipanalytical skillscommunicationmentoringcollaborationproblem-solvinginterpersonal skillsteam managementstrategic planningbusiness development

Certifications

RACASQ CQEASQ CQA