Quality Manager

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges. Position SummaryOur Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies, and ELISA kits used to support academic, government, biotech, and pharmaceutical customers. The Quality Manager is part of the Cranbury Recombinant Proteins Quality organization and reports to the Director, Quality. This role provides Quality leadership for the PeproGMP product portfolio and leads the site’s Quality Control organization, with responsibility for ensuring effective Quality oversight, laboratory execution, and continuous improvement in support of manufacturing and business needs. How will you make an impact?The Quality Manager provides leadership and operational direction for Quality Assurance activities supporting the PeproGMP product portfolio and for Quality Control operations at the Cranbury site. This role leads and develops Quality team members, strengthens Quality and laboratory processes, and partners closely with Operations, Manufacturing Sciences, Quality colleagues, and other cross-functional stakeholders to resolve product and process quality issues and drive sustainable improvement. Through strong Quality judgment, risk-based decision making, and cross-functional collaboration, the Quality Manager strengthens execution of applicable quality requirements, supports ISO 9001 and Quality Management System effectiveness, improves QC performance, and helps advance product quality, customer outcomes, and operational excellence across the Thermo Fisher Scientific Cranbury organization. What will you do?Provide Quality leadership and oversight for the PeproGMP product portfolio, ensuring effective execution of established Quality Management System, product, customer, GMP, and applicable regulatory requirements. Lead, develop, and manage the Cranbury Quality Control team, ensuring effective laboratory operations, building team capability, and driving consistent execution of testing and Quality Control priorities. Manage and support the effectiveness of the Cranbury Quality Management System and ISO 9001 certification, ensuring requirements are effectively implemented, maintained, and continuously improved within assigned areas of responsibility. Ensure effective execution and timely progression of quality records, including nonconformances, deviations, CAPAs, change controls, and customer complaints, providing appropriate Quality oversight and driving high-quality investigations, root cause analysis, and sustainable resolution. Leverage Quality and QC performance data and trends to identify risks and improvement opportunities, drive deeper analysis when warranted, and partner with Operations and cross-functional teams to improve product quality, process performance, laboratory effectiveness, and customer outcomes. Provide Quality leadership for significant product, process, and laboratory quality decisions and escalations, using sound Quality judgment and risk-based decision making to appropriately balance product quality, customer requirements, compliance, and business needs. Partner closely with Operations, Manufacturing Sciences, Regulatory Affairs, R&D, Quality colleagues, and other key stakeholders to troubleshoot product and process issues, evaluate data, determine appropriate Quality actions, and drive effective, sustainable solutions. Support customer Quality activities, including customer audits, Quality Agreements, quality inquiries, and significant customer concerns, ensuring appropriate Quality representation of the Cranbury operation. Maintain audit and inspection readiness and lead or support internal, external, customer, and ISO certification audits within assigned areas of responsibility, ensuring timely and effective resolution of resulting actions. Champion Practical Process Improvement (PPI), Thermo Fisher Scientific’s continuous improvement methodology, across Quality and QC activities to improve effectiveness, efficiency, product quality, and customer experience. Develop team capability through coaching, training, performance management, and clear accountability while fostering a culture of quality, data integrity, collaboration, and continuous improvement. Partner across the Cranbury Quality organization and provide Quality leadership and support for additional products, processes, or operational priorities as business needs evolve. How will you get here?EducationBachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Microbiology, Biomedical Engineering, or a related scientific or technical discipline required. Advanced degree in a scientific, technical, Quality, or business discipline preferred. ExperienceMinimum of 7 years of progressive experience in Quality Assurance, Quality Control, Quality Systems, or related Quality functions within the life sciences or regulated manufacturing industry, including demonstrated experience supporting GMP-controlled products or environments. Minimum of 3 years of people leadership experience, with demonstrated success leading, developing, and building capability within Quality teams. Demonstrated experience applying GMP requirements and Quality practices within manufacturing, laboratory, or controlled environments. Experience with ISO 9001 Quality Management Systems and certification requirements, including implementation, maintenance, audit support, and continuous improvement. Experience providing Quality oversight for investigations, nonconformances, deviations, CAPAs, change controls, and customer complaints. Experience leading or supporting Quality Control laboratory operations, analytical testing activities, laboratory investigations, or other QC functions within a life sciences environment. Demonstrated experience partnering with Operations and technical functions to resolve complex product and process quality issues and drive sustainable improvements. Experience interacting with customers and auditors, including supporting or leading customer, certification, or other Quality audits. Knowledge, Skills & AbilitiesStrong knowledge of Quality Assurance and Quality Management System principles and practices within a life sciences manufacturing environment. Strong working knowledge of GMP requirements and quality practices for life sciences manufacturing, including 21 CFR Part 11 requirements for electronic records and electronic signatures, data integrity principles, and applicable FDA and international quality expectations. Working knowledge of 21 CFR Part 820/QMSR requirements and relevant ICH quality guidelines, including Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10), with the ability to translate these requirements and principles into effective Quality controls and risk-based practices. Strong knowledge of ISO 9001 requirements and demonstrated ability to support an effective, compliant, and continuously improving Quality Management System. Strong understanding of controlled-environment manufacturing practices and the Quality controls necessary to support PeproGMP manufacturing. Working knowledge of Quality Control laboratory operations, analytical testing, laboratory investigations, and laboratory quality prac