Senior Executive Director Quality Assurance, Global Central Laboratories

Work Schedule

Environmental Conditions

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 laboratorys 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 laboratorys 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

• Bachelors degree in Life Sciences Chemistry Biochemistry Medical Technology or a related field (Masters 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