Quality Manager

Thermo Fisher Scientific • Cranbury, NJ

27d • $103,100 - $137,500 • Onsite

About The Position

The Quality Manager provides Quality leadership for the PeproGMP product portfolio and leads the Quality Control organization at Thermo Fisher Scientific’s Cranbury, New Jersey site. The role provides oversight of Quality Assurance activities, laboratory execution, and continuous improvement in support of manufacturing and business needs. It leads and develops Quality team members and partners with Operations, Manufacturing Sciences, Regulatory Affairs, R&D, Quality colleagues, and other stakeholders to resolve product and process quality issues and improve outcomes.

The position supports effective execution of applicable Quality Management System, product, customer, GMP, and regulatory requirements; ISO 9001 certification and QMS effectiveness; and audit and inspection readiness. It uses Quality judgment, risk-based decision-making, and performance data to strengthen Quality and QC processes, support customer outcomes, and advance operational excellence. The position reports to the Director, Quality.

The role is based in a cleanroom environment with restrictions on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair. The work schedule is standard Monday through Friday.

Requirements

• Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Microbiology, Biomedical Engineering, or a related scientific or technical discipline.
• At least 7 years of progressive experience in Quality Assurance, Quality Control, Quality Systems, or related Quality functions in life sciences or regulated manufacturing, including experience supporting GMP-controlled products or environments.
• At least 3 years of people leadership experience, including leading, developing, and building capability within Quality teams.
• Experience applying GMP requirements and Quality practices in 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, laboratory investigations, or other QC functions in a life sciences environment.
• 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.
• Strong knowledge of Quality Assurance and Quality Management System principles and practices in life sciences manufacturing.
• Working knowledge of GMP requirements, 21 CFR Part 11, data integrity, and applicable FDA and international quality expectations.
• Working knowledge of 21 CFR Part 820/QMSR and relevant ICH quality guidelines, including ICH Q9 and ICH Q10, and the ability to translate them into effective Quality controls and risk-based practices.
• Knowledge of controlled-environment manufacturing practices and Quality controls supporting PeproGMP manufacturing.
• Working knowledge of QC laboratory operations, analytical testing, laboratory investigations, and laboratory quality practices.
• Strong knowledge and practical application of root cause analysis, CAPA, change control, risk management, and structured problem-solving methodologies.
• Ability to use Quality and laboratory performance data and trends to identify risks, establish priorities, and drive operational improvement.
• Leadership and people-development capabilities, including team building, talent development, accountability, and leading through change.
• Ability to exercise sound Quality judgment and make timely, risk-based decisions involving product quality, manufacturing, laboratory operations, customer needs, and business priorities.
• Cross-functional leadership and influencing skills, including the ability to challenge, align, and partner with Operations, Manufacturing Sciences, Regulatory Affairs, R&D, Quality colleagues, and business leadership.
• Customer-facing communication skills to represent Quality during discussions, audits, Quality Agreement activities, and resolution of significant quality concerns.
• Knowledge and application of continuous improvement principles and methodologies; ability to apply Thermo Fisher Scientific’s PPI methodology.
• Excellent written and verbal communication skills to communicate Quality risks, priorities, recommendations, and decisions to technical teams, business stakeholders, and senior leadership.
• Organizational and prioritization skills to manage multiple Quality and laboratory priorities, escalate significant risks, and drive issues to resolution independently.
• Proficiency with standard business applications and electronic Quality/compliance systems.
• Commitment to workplace safety, data integrity, product quality, customer focus, and continuous improvement.
• Compliance with cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair.

Nice To Haves

• Advanced degree in a scientific, technical, Quality, or business discipline.
• Experience applying Lean, Six Sigma, or similar continuous improvement approaches.

Responsibilities

• Provide Quality leadership and oversight for the PeproGMP product portfolio, ensuring effective execution of the Quality Management System and applicable product, customer, GMP, and regulatory requirements.
• Lead, develop, and manage the Cranbury Quality Control team, supporting effective laboratory operations, team capability, and consistent execution of testing and QC priorities.
• Manage and support the effectiveness of the Cranbury Quality Management System and ISO 9001 certification, including implementation, maintenance, and continuous improvement within assigned areas.
• Oversee quality records, including nonconformances, deviations, CAPAs, change controls, and customer complaints; drive high-quality investigations, root cause analysis, and sustainable resolution.
• Use Quality and QC performance data and trends to identify risks and improvement opportunities 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, risk-based judgment.
• Partner with Operations, Manufacturing Sciences, Regulatory Affairs, R&D, Quality colleagues, and other stakeholders to troubleshoot issues, evaluate data, determine Quality actions, and implement sustainable solutions.
• Support customer Quality activities, including customer audits, Quality Agreements, inquiries, and significant customer concerns.
• Maintain audit and inspection readiness and lead or support internal, external, customer, and ISO certification audits; ensure timely and effective resolution of resulting actions.
• Champion Practical Process Improvement (PPI) across Quality and QC activities to improve effectiveness, efficiency, product quality, and customer experience.
• Develop team capability through coaching, training, performance management, and accountability while fostering quality, data integrity, collaboration, and continuous improvement.
• Provide Quality leadership and support for additional products, processes, or operational priorities as business needs evolve.

Benefits

• 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 of paid time off and 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offers eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager