Quality Manager

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.

What will you do?

1. 1Provide Quality leadership and oversight for the PeproGMP product portfolio, ensuring effective execution of established Quality Management System, product, customer, GMP, and applicable regulatory requirements.
2. 2Lead, 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.
3. 3Manage 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.
4. 4Ensure 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.
5. 5Leverage 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.
6. 6Provide 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.
7. 7Partner 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.
8. 8Support customer Quality activities, including customer audits, Quality Agreements, quality inquiries, and significant customer concerns, ensuring appropriate Quality representation of the Cranbury operation.
9. 9Maintain 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.
10. 10Champion 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.
11. 11Develop team capability through coaching, training, performance management, and clear accountability while fostering a culture of quality, data integrity, collaboration, and continuous improvement.
12. 12Partner across the Cranbury Quality organization and provide Quality leadership and support for additional products, processes, or operational priorities as business needs evolve.

• Medical, dental and vision plans

• Paid time off and 10 paid holidays

• Paid parental leave

• 401(k) retirement savings plan

• Employee Stock Purchase Plan

• Tuition reimbursement

Environmental Conditions