Associate Director, QA Global Central Laboratories

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description We are seeking an Associate Director, Quality Assurance to lead a team of QA professionals supporting the primary location of the Global Central Laboratories Quality Assurance organization. This role will be based in the Highland Heights, Kentucky / Cincinnati metropolitan region and will provide quality leadership for central laboratory operations, including clinical laboratory services, kitting operations, biorepository activities and related quality systems. The Associate Director will be responsible for leading the site-based QA team, maintaining a strong quality culture, supporting inspection readiness, ensuring effective quality system execution and partnering closely with laboratory operations and GCL leadership. This role requires an experienced QA leader with strong laboratory quality, regulatory compliance, people leadership and continuous improvement experience. The successful candidate will bring practical experience with laboratory quality systems and applicable standards such as CLIA, CAP, ISO 15189, New York State requirements, FDA, EMA, and other relevant regulatory and accreditation expectations. Key Responsibilities Quality Assurance Leadership Lead, coach and mentor a team of QA professionals supporting the primary Global Central Laboratories location. Provide day-to-day and strategic QA leadership for assigned laboratory, kitting, biorepository and related quality system activities. Support development, execution and continuous improvement of the laboratory quality assurance program. Promote a quality culture focused on accountability, accuracy, reliability, inspection readiness, data integrity and continuous improvement. Partner with laboratory operations, GCL leadership and senior QA leadership to align local quality priorities with business and regulatory expectations. Ensure the QA team is organized, trained and resourced to support operational needs, client commitments and compliance obligations. Serve as a key QA partner to site and functional leaders in identifying quality risks, resolving issues and improving processes. Regulatory Compliance and Accreditation Ensure quality systems and site practices support compliance with applicable regulatory, accreditation, client and internal requirements. Support compliance with relevant standards and expectations, including CLIA, CAP, ISO 15189, NYS, FDA, EMA, and other applicable requirements. Represent QA during client audits, regulatory authority inspections and accreditation assessments. Lead or support internal audits, external audits and inspection readiness activities. Ensure audit and inspection findings are evaluated, escalated as appropriate and addressed through timely and effective corrective and preventive actions. Advise site teams on interpretation and implementation of regulatory expectations, accreditation standards, quality trends and industry best practices. Remain informed about changing regulatory requirements and industry methodologies relevant to central laboratory operations. Quality Management Systems, CAPA and Risk Management Lead assigned quality management system processes, which may include deviations, investigations, CAPA, change control, document control, audit management, training, quality metrics and risk management. Ensure quality events, nonconformances and audit findings are investigated with appropriate root cause analysis and documented rationale. Partner with operations and technical teams to develop effective, practical and sustainable corrective and preventive actions. Track, trend and report quality metrics and KPIs to evaluate site performance and identify improvement opportunities. Identify and escalate significant quality, compliance, data integrity or operational risks to site and QA leadership. Support risk management strategies that reduce potential compliance, quality, client delivery and patient-impacting risks. Assess CAPA effectiveness and drive timely closure of quality actions. Process Improvement and Operational Partnership Partner with laboratory operations, kitting, biorepository and support functions to identify and implement process improvements. Lead or participate in cross-functional initiatives to improve quality system performance, operational efficiency and compliance. Use proven problem-solving techniques to address nonconformance, recurring issues and quality trends. Provide practical QA guidance to support operational decision-making while maintaining compliance with applicable requirements. Support client-facing quality discussions, proposals, audit responses and issue resolution as needed. Help translate quality and compliance requirements into clear expectations for site teams. Team Leadership and Staff Development Hire, develop, mentor and manage QA staff to build capability and support strong performance. Assign work, establish priorities, monitor progress and ensure completion of departmental goals and objectives. Provide regular coaching, feedback and performance management for direct reports. Support training and development of QA professionals in quality systems, regulatory expectations, inspection readiness, technical writing, problem solving and effective stakeholder engagement. Foster a team environment built on accountability, collaboration, inclusion, technical excellence and continuous improvement. Ensure consistent application of organizational policies, procedures and quality expectations within the QA team. Documentation and Reporting Support oversight of controlled documents, including SOPs, protocols, forms, quality manuals and related documentation. Ensure quality records are complete, accurate, timely and maintained in accordance with applicable requirements. Provide routine updates to leadership on quality performance, audit and inspection outcomes, CAPA status, compliance risks and key quality trends. Analyze quality and compliance data and escalate critical nonconformance or emerging risks to appropriate leadership. Support preparation of quality reports, leadership reviews and inspection readiness materials. Supervisory Responsibilities Supervises the daily activities of QA professionals supporting the primary Global Central Laboratories location. May supervise professional-level individual contributors and/or lower-level managers depending on organizational structure. Responsibilities include training and developing staff, assigning work, setting priorities, supporting completion of departmental objectives, assisting with complex quality issues, interpreting organizational policies and ensuring consistent application of quality procedures and expectations. May recommend or initiate personnel actions, including hiring, performance feedback, development plans, promotion recommendations, time off approvals, timesheet approvals and expense report approvals in accordance with company procedures. Qualifications and Requirements Education and Experience Bachelor’s degree or equivalent and relevant formal academic/vocational qualification in life sciences, chemistry, biochemistry, medical technology, clinical laboratory science, quality, regulatory affairs or a related field. Previous experience that provides the knowledge, skills and abilities to perform the job, typically comparable to 10+ years in quality assurance, laboratory quality, clinical diagnostics, pharmaceutical, biotech, CRO or regulated healthcare/laboratory environments. 5+ years of management responsibility or demonstrated experience leading QA teams, quality programs or complex quality initiatives. Experience with laboratory quality systems, regulatory compliance, accreditation standards and audit/inspection support. Experience in a central laboratory, high-complexity laboratory, clinical diagnostics, biorepository, kitting, pharmaceutical, biotech or clinical research environment preferred. Equivalent