Executive Director Quality Assurance Bioanalytical and Vaccine Laboratories

Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

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.

The Executive Director Quality Assurance coordinates and ensures compliance with all quality assurance standards and regulatory requirements in the Bioanalytical and Vaccine laboratory environment. 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, FDA, 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
• 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 management level staff in the daily operations of a business unit. May also supervise professional level individual contributors. Responsible for training and development of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, assisting subordinates with difficult inquiries or problems, interpreting and ensuring consistent application of organizational policies, and development and implementation of unit policies and procedures. Recommends employees for employment, improvement action, termination; initiates and communicates a variety of personnel actions (e.g. performance and salary reviews, promotions, time off requests, timesheet and expense report approvals).

Qualifications & Requirements:

Education & Experience

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Medical Technology, or a related field (Master's or Ph.D. preferred)
• 10+ years of experience in laboratory quality assurance, with at least 5 years in a senior leadership role
• Extensive experience in regulatory compliance (CLIA, CAP, FDA, ISO 15189, GMP/GLP, 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

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. Below is listed the working environment/requirements for this role:

• This is an onsite position in our Richmond, VA laboratory.
• Overnight travel, including international, approximately 10% may be required.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.