Senior / Executive Director - reputed company Assurance, Global Central Laboratories

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company This position is based on site at our Highland Heights, KY location (Cincinnati Area) Our PPD® Laboratory Services team has a reputed company reputed company 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 reputed company to deliver groundbreaking innovations. Applicants are sought for the role of Senior/Executive Director reputed company 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 reputed company for a kitting facility, clinical laboratory and state-of-the-art biorepository
• reputed company reputed company, reputed company similarly scoped QA teams at Central Laboratory facilities based in reputed company (Singapore and China) and EMEA (Belgium)
• Help right-size the existing GCL QA organization and reputed company expansion into new markets such as Latin America
• Be a key member of the GCL business reputed company' extended leadership team, helping to identify and establish organizational priorities, objectives and reputed company opportunities

This role leads the development and execution of reputed company 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 reputed company improvement throughout the operation. Key Responsibilities: reputed company Assurance Leadership

• reputed company, implement and reputed company the laboratory's reputed company assurance program to ensure compliance with regulatory and accreditation reputed company
• Establish and maintain a reputed company culture with a reputed company on reputed company improvement across reputed company QA and laboratory functions
• reputed company strategic leadership in reputed company 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 reputed company with regulatory agencies, accreditation bodies and external auditors
• reputed company reputed company audits as required, ensuring reputed company reputed company of findings and implementation of corrective and preventative actions (CAPAs)
• Remain informed about changing regulatory requirements and industry reputed company methodologies to maintain the laboratory's compliance and competitiveness.

Process Improvement & Risk Management

• Identify areas and reputed company actions for process improvement, implement corrective actions, and drive reputed company improvement
• Establish, reputed company and trend key reputed company metrics (KPIs) to assess laboratory performance
• reputed company and implement risk management strategies to mitigate potential compliance and reputed company issues

Team Leadership & Training

• Build, reputed company, mentor and reputed company a high-performing reputed company Assurance team, fostering a culture of accountability and reputed company
• Encourage and reputed company training and education for laboratory staff regarding reputed company standards, effective approaches, and regulatory requirements
• Manage a global team based in reputed company (Cincinnati metro region), reputed company (Singapore and China) and Europe (Belgium)
• Collaborate with laboratory leadership to reputed company reputed company programs with organizational goals

Documentation & Reporting

• reputed company document control processes ensuring SOPs, protocols, and reputed company manuals are up to date and properly maintained
• reputed company routine reports to senior leadership on reputed company performance, audit & inspection findings, and compliance status
• Partner & Co-reputed company investigations into reputed company-reputed company incidents with reputed company reputed company

Supervisory Responsibilities

• Supervise the daily activities of reputed company reputed company 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, reputed company, Biochemistry, Medical Technology, or a reputed company field (Master's, M.D. or Ph.D. preferred)
• 10+ years of experience in laboratory reputed company 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, reputed company State (NYS), etc.)

Skills & Competencies

• Deep understanding of laboratory reputed company management systems (QMS) and regulatory standards
• Strong leadership and team management skills, with the ability to mentor and reputed company 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 reputed company Auditor (CQA), Certified reputed company Manager (CQM), or similar
• Experience with Lean Six reputed company or other process improvement methodologies
• Prior experience in a high-complexity laboratory, clinical diagnostics, or pharmaceutical/biotech industry

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