Senior / Executive Director - Quality Assurance, Global Central Laboratories

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This position is based on site at our Highland Heights, KY location (Cincinnati Area) Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Applicants are sought for the role of Senior/Executive Director Quality Assurance leading the Global Central Laboratories QA organization. This is a great opportunity for senior leaders with

CLIA/CAP/ISO-15189

experience. Specifically, in this role you will: Be based in the Cincinnati metropolitan region with QA oversight for a kitting facility, clinical laboratory and state-of-the-art biorepository Beyond North America, lead similarly scoped QA teams at Central Laboratory facilities based in APAC (Singapore and China) and EMEA (Belgium) Help right-size the existing GCL QA organization and enable expansion into new markets such as Latin America Be a key member of the GCL business units extended leadership team, helping to identify and establish organizational priorities, objectives and growth opportunities This role leads the development and execution of quality strategies, policies, and systems to maintain the highest standards of accuracy, reliability, and regulatory adherence in laboratory operations. The position requires strong leadership, expertise in regulatory compliance (e.g., CLIA, CAP, NYS, ISO 15189), and the ability to drive continuous improvement throughout the operation.

Key Responsibilities:

Quality Assurance Leadership Develop, implement and lead the laboratory's quality assurance program to ensure compliance with regulatory and accreditation standard Establish and maintain a quality culture with a focus on continuous improvement across all QA and laboratory functions Provide strategic leadership in quality management systems (QMS) to enhance operational efficiency and compliance Regulatory Compliance Accreditation Ensure compliance with relevant regulations, including

CLIA, CAP, FDA, EMA, ISO

15189, GMP/GLP and other applicable standards Serve as the primary liaison with regulatory agencies, accreditation bodies and external auditors Lead internal and external audits as required, ensuring timely resolution of findings and implementation of corrective and preventative actions (CAPAs) Remain informed about changing regulatory requirements and industry standard methodologies to maintain the laboratory's compliance and competitiveness. Process Improvement & Risk Management Identify areas and direct actions for process improvement, implement corrective actions, and drive continuous improvement Establish, track and trend key quality metrics (KPIs) to assess laboratory performance Develop and implement risk management strategies to mitigate potential compliance and quality issues Team Leadership & Training Build, lead, mentor and develop a high-performing Quality Assurance team, fostering a culture of accountability and excellence Encourage and provide training and education for laboratory staff regarding quality standards, effective approaches, and regulatory requirements Manage a global team based in North America (Cincinnati metro region), APAC (Singapore and China) and Europe (Belgium) Collaborate with laboratory leadership to align quality programs with organizational goals Documentation & Reporting Oversee document control processes ensuring SOPs, protocols, and quality manuals are up to date and properly maintained Provide routine reports to senior leadership on quality performance, audit & inspection findings, and compliance status Partner & Co-Lead investigations into quality-related incidents with timely resolution Supervisory Responsibilities Supervise the daily activities of all levels of staff in the daily operations of a business unit including training and development, staff resourcing, performance management, etc.

Qualifications & Requirements:

Education & Experience Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Medical Technology, or a related field (Master's, M.D. or Ph.D. preferred) 10+ years of experience in laboratory quality assurance, with at least 5 years in a senior leadership role. Medical Director experience may also apply Extensive experience in regulatory compliance (CLIA, CAP, FDA, ISO 15189, New York State (NYS), etc.) Skills & Competencies Deep understanding of laboratory quality management systems (QMS) and regulatory standards Strong leadership and team management skills, with the ability to mentor and develop staff Excellent problem-solving, analytical, and decision-making abilities Strong communication and collaboration skills, with the ability to engage with cross-functional teams and regulatory agencies Experience with audit management, CAPA systems, and risk assessment methodologies Preferred Qualifications Certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or similar Experience with Lean Six Sigma or other process improvement methodologies Prior experience in a high-complexity laboratory, clinical diagnostics, or pharmaceutical/biotech industry Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.