Provide leadership and governance for audits and inspections across CLS in alignment with ISO 15189, CAP, CLIA, NYS/MOH, and GCP requirements
Job Summary
Provide leadership and governance for audits and inspections across CLS in alignment with ISO 15189, CAP, CLIA, NYS/MOH, and GCP requirements.
Ensure consistent implementation, review, and governance of SOPs, policies, and controlled documents, translating regulatory requirements into practical, operational quality controls.
Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
Matching Summary
Provide leadership and governance for audits and inspections across CLS in alignment with ISO 15189, CAP, CLIA, NYS/MOH, and GCP requirements.
Skills & Requirements
Must-have
ISO 15189, CAP, CLIA, NYS/MOH, GCP
Data integrity programs
Internal audit programs
Cross-functional stakeholder influence
Vendor qualification and oversight
Nice-to-have
Coaching and performance feedback
Process improvement initiatives
Management reviews
Key Requirements
8+ years of experience in a regulated environment
Bachelor’s degree in Life Sciences (or equivalent experience)