Hiring: Associate Director, QA Global Central Laboratories Company: Thermo Fisher Scientific Location: Highland Heights, KY Job Posted Time: 2026-09-10 07:40:48 Target Skills & Keywords : Regulatory Compliance About the job Experience: •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. Required Skills: •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. Qualifications: •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. •In-depth knowledge of regulatory interpretation, documentation practices, and quality systems. •Excellent leadership, coaching, communication, stakeholder management, analytical, and problem-solving skills. •Demonstrated capacity 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. •Bachelor's degree (or equivalent) in Life Sciences, Chemistry, Biochemistry, Medical Technology, Clinical Laboratory Science, Quality, Regulatory Affairs, or a related field. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!