Quality Manager

Work Schedule

Environmental Conditions

Job Description

LOCATION: This is a fully onsite position based at our Cranbury, NJ site. Unfortunately, relocation assistance is NOT provided. Priority will be given to LOCAL candidates currently residing in Cranbury area.

• Must be legally authorized to work in the United States without sponsorship now or in the future.
• Must be able to pass a comprehensive background check, which includes a drug screen.

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 Summary

Our 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?

Education

• Bachelor’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.

Experience

• Minimum 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 & Abilities

• Strong 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 practices.
• Strong understanding of data integrity principles and electronic Quality records and systems, with the ability to ensure appropriate controls within laboratory and manufacturing operations.
• Strong knowledge and practical application of root cause analysis, CAPA, change control, risk management, and structured problem-solving methodologies.
• Demonstrated ability to use Quality and laboratory performance data and trends to identify risk, establish priorities, and drive operational improvement.
• Strong leadership and people-development capabilities, with the ability to build effective teams, develop talent, establish clear accountability, and lead through change.
• Demonstrated ability to exercise sound Quality judgment and make timely, risk-based decisions involving product quality, manufacturing, laboratory operations, customer needs, and business priorities.
• Strong cross-functional leadership and influencing skills, with the ability to effectively challenge, align, and partner with Operations, Manufacturing Sciences, Regulatory Affairs, R&D, Quality colleagues, and Business Leadership.
• Strong customer-facing communication skills with the ability to represent Quality effectively during customer discussions, audits, Quality Agreement activities, and resolution of significant quality concerns.
• Strong knowledge and application of continuous improvement principles and methodologies, with experience applying Lean, Six Sigma, or similar approaches; ability to effectively apply Thermo Fisher Scientific’s Practical Process Improvement (PPI) methodology.
• Excellent written and verbal communication skills, with the ability to communicate Quality risks, priorities, recommendations, and decisions to audiences ranging from technical teams to business and senior leadership.
• Strong organizational and prioritization skills, with the ability to manage multiple Quality and laboratory priorities, appropriately escalate significant risks, and independently drive issues to resolution.
• Proficiency with standard business applications and electronic Quality/compliance systems used to manage, analyze, and communicate Quality information.
• Commitment to workplace safety, data integrity, product quality, customer focus, and a culture of continuous improvement.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards