Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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