Senior / Executive Director - Quality Assurance, Global Central Laboratories

Thermo Fisher Scientific • Highland Heights, KY

1d • Onsite

About The Position

This position is based on site at the Highland Heights, KY location (Cincinnati Area) within the PPD® Laboratory Services team. The role is for a Senior/Executive Director Quality Assurance leading the Global Central Laboratories QA organization, specifically seeking senior leaders with CLIA/CAP/ISO-15189 experience. The role involves QA oversight for a kitting facility, clinical laboratory, and state-of-the-art biorepository in North America, as well as leading similarly scoped QA teams at Central Laboratory facilities in APAC (Singapore and China) and EMEA (Belgium). The director will help right-size the existing GCL QA organization, enable expansion into new markets like Latin America, and serve as a key member of the GCL business unit's extended leadership team, identifying and establishing organizational priorities, objectives, and growth opportunities. This role is responsible for leading the development and execution of quality strategies, policies, and systems to maintain the highest standards of accuracy, reliability, and regulatory adherence in laboratory operations, requiring strong leadership, expertise in regulatory compliance (e.g., CLIA, CAP, NYS, ISO 15189), and the ability to drive continuous improvement.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Medical Technology, or a related field
• 10+ years of experience in laboratory quality assurance
• 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.)
• 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

Nice To Haves

• Master's, M.D. or Ph.D. preferred
• 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

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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.

Benefits

• Reasonable accommodation for individuals with disabilities to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees