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 combinations of education, training and directly related experience may be considered.
Knowledge, Skills and Abilities
Strong knowledge of laboratory quality management systems and applicable regulatory/accreditation standards, including CLIA, CAP, ISO 15189, NYS, FDA, EMA, GMP/GLP and related expectations.
Demonstrated ability to lead QA professionals in a regulated laboratory environment.
Strong understanding of audit management, CAPA, investigations, root cause analysis, quality metrics, inspection readiness and data integrity principles.
Demonstrated proficiency in regulation and guideline interpretation, proper documentation practices and QA departmental policies and procedures.
Strong leadership, coaching and team management skills, with the ability to mentor and develop staff.
Excellent verbal and written communication skills, including the ability to communicate complex quality, regulatory, medical and scientific information clearly.
Ability to interact effectively with laboratory operations, senior management, clients, regulatory agencies and accreditation bodies.
Strong problem-solving, analytical and decision-making abilities.
Ability to apply business and process improvement methodologies, including Lean Six Sigma or similar approaches preferred.
Ability to manage complex projects and priorities in a fast-paced, matrixed environment.
Strong business acumen, including understanding of quality, compliance, client delivery and operational performance expectations.
Certifications such as ASQ Certified Quality Auditor, Certified Quality Manager, Lean Six Sigma or similar credentials preferred.
Policy and Strategy
Establishes or contributes to operating policies and procedures for assigned QA areas. Interprets company-wide policies and procedures and applies them to site quality and compliance activities. May contribute to departmental budgets, staffing plans, schedules, quality plans, performance standards and site quality objectives in alignment with senior leadership direction.
Management Role
Leads a team of QA professionals supporting the primary location of the Global Central Laboratories Quality Assurance organization. Directs work through professional staff and may lead lower-level managers or highly skilled specialists. Exercises independent judgment in the execution of quality programs, issue resolution, staff development, quality system oversight and cross-functional partnership.
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
This is a hybrid position in the Highland Heights, Kentucky / Cincinnati metropolitan region laboratory.
Work is primarily performed in an office and laboratory environment.
May support activities in a clinical laboratory, kitting facility, biorepository or related regulated environment.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Domestic and occasional international travel may be required based on business, client, audit, inspection or site support needs.
Able to use and learn standard office equipment and technology with proficiency.
Able to communicate, receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Physical Requirements
Frequently stationary for typical working hours.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists.
Moderate mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying, or otherwise moving objects including luggage and laptop computer, typically up to 15-25 pounds.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Frequently interacts with others and may communicate sensitive information to diverse groups both internally and externally.
Performs a wide range of variable tasks as dictated by business demands and changing conditions.
Ability to perform under stress, multi-task and maintain regular and consistent attendance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
