QC Laboratory Manager/Quality Engineer

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Manager, QC Laboratory & Quality Engineer 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 every day to enable our customers to make the world healthier, cleaner, and safer.We empower our teams with the resources, support, and opportunities needed to achieve their career goals while helping solve some of the world's toughest challenges—from protecting the environment and ensuring food safety to advancing life-saving therapies and treatments. About the RoleThermo Fisher Scientific is seeking a Manager, QC Laboratory & Quality Engineer to join our Quality Assurance team. This unique dual-role opportunity combines leadership of our Quality Control Laboratory with site-level Quality Engineering responsibilities, offering broad exposure across manufacturing, operations, engineering, and quality systems. In this role, you will lead QC laboratory operations and personnel while driving quality improvement initiatives that strengthen compliance, reduce risk, improve operational performance, and enhance customer satisfaction. You will partner closely with Operations, Engineering, Manufacturing, Supply Chain, and Site Leadership to ensure the highest standards of product quality and regulatory compliance. This is an excellent opportunity for a quality professional who enjoys balancing people leadership with hands-on quality engineering and continuous improvement activities. Key ResponsibilitiesLead daily operations of the QC Laboratory, including supervision, development, and performance management of laboratory personnel. Ensure laboratory activities are conducted in compliance with applicable cGMP, ISO, regulatory, and company requirements. Drive site quality engineering initiatives focused on risk reduction, process improvement, and quality system effectiveness. Support and lead investigations, deviations, nonconformances, CAPAs, and root cause analyses. Partner with cross-functional teams to improve manufacturing processes, product quality, and operational performance. Support validation activities and quality risk management programs. Participate in internal audits, customer audits, and regulatory inspections. Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization. Develop and deliver quality-related training and guidance to site personnel. Required QualificationsBachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline. Minimum of 5 years of quality experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or related industry). Minimum of 2 years of supervisory or team leadership experience. Strong knowledge of cGMP regulations, quality systems, and applicable ISO standards. Experience applying quality risk management principles and tools. Demonstrated ability to lead initiatives, solve complex problems, and influence cross-functional teams. Preferred QualificationsASQ certifications such as CQE, CQA, or equivalent. Experience with batch record review, deviation management, CAPA, and change control systems. Experience implementing quality improvements and continuous improvement initiatives. Knowledge of validation principles and quality engineering methodologies. Experience hosting regulatory inspections and customer audits. Familiarity with electronic quality management systems such as TrackWise and SAP. Strong project management, organizational, and communication skills. Ability to manage multiple priorities in a fast-paced manufacturing environment. Why Join Thermo Fisher Scientific?Lead a high-impact QC laboratory team while expanding your quality engineering expertise. Gain visibility and influence across multiple functions and site leadership. Contribute directly to products and solutions that improve lives around the world. Grow your career within a global organization committed to innovation, development, and scientific advancement. Join us and help make a difference—every day.