Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Associate Director, Quality Assurance – Global Central Laboratories

The Associate Director, Quality Assurance provides strategic and operational leadership for the Quality Assurance team supporting the primary Global Central Laboratories (GCL) site in the Highland Heights, KY/Cincinnati region. This role oversees quality systems supporting clinical laboratory services, biorepository, kitting operations, and related activities while ensuring compliance with regulatory, accreditation, client, and company requirements. The position partners closely with laboratory operations and senior leadership to foster a culture of quality, inspection readiness, continuous improvement, and operational excellence.

Key Responsibilities

• Lead, mentor, and develop a team of QA professionals supporting laboratory quality operations.

• Oversee quality management systems, including deviations, investigations, CAPA, change control, document control, audits, training, risk management, and quality metrics.

• Ensure compliance with applicable regulations and accreditation standards, including CLIA, CAP, ISO 15189, New York State, FDA, EMA, GMP/GLP, and related requirements.

• Lead and support internal audits, client audits, regulatory inspections, and accreditation assessments while driving inspection readiness.

• Partner cross-functionally to identify quality risks, resolve compliance issues, implement process improvements, and support continuous improvement initiatives.

• Monitor quality trends, analyze performance metrics, and provide leadership with recommendations to improve quality, compliance, and operational performance.

• Support client interactions, regulatory responses, and quality-related business initiatives.

Minimum Education & Experience

• Bachelor's degree (or equivalent) in Life Sciences, Chemistry, Biochemistry, Medical Technology, Clinical Laboratory Science, Quality, Regulatory Affairs, or a related field.

• 10+ years of experience in Quality Assurance within regulated laboratory, clinical diagnostics, pharmaceutical, biotechnology, CRO, or healthcare environments.

• 5+ years of leadership or management experience leading QA teams, quality programs, or complex quality initiatives.

• Experience with laboratory quality systems, regulatory compliance, accreditation standards, and audit/inspection support. Experience in central laboratories, high-complexity laboratories, biorepositories, or clinical research environments is preferred.

Critical Knowledge, Skills & Abilities

• Strong knowledge of laboratory quality management systems and regulatory/accreditation standards, including CLIA, CAP, ISO 15189, NYS, FDA, EMA, GMP/GLP.

• Demonstrated leadership experience managing QA teams in regulated laboratory environments.

• Expertise in CAPA, investigations, root cause analysis, audit management, inspection readiness, data integrity, risk management, and quality metrics.

• Strong understanding of regulatory interpretation, documentation practices, and quality systems.

• Excellent leadership, coaching, communication, stakeholder management, analytical, and problem-solving skills.

• Ability to lead cross-functional initiatives, manage multiple priorities, and drive continuous improvement in a matrixed environment.

• Lean Six Sigma and/or ASQ Quality certifications are preferred.