Sr Quality Manager

Thermo Fisher Scientific • Marietta, OH

1d • Onsite

About The Position

This role is for a Senior Quality Manager at Thermo Fisher Scientific in Marietta, Ohio. The position requires a hands-on, pragmatic Quality leader who can build strong partnerships with Operations, develop a high-performing Quality organization, solve complex manufacturing challenges, and improve site operations. The ideal candidate is passionate about developing people, improving manufacturing processes, making sound risk-based decisions, and creating a culture where Quality and Operations succeed together. The Senior Manager, Quality will be a key member of both the Marietta Site Leadership Team and the Divisional Quality & Regulatory Leadership Team, collaborating with divisional leaders to shape strategy, strengthen organizational capability, share best practices, and drive consistent standards and continuous improvement across the broader division.

Requirements

• Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Life Sciences, Chemistry, or another related technical discipline.
• 10+ years of progressive experience across manufacturing, operations, engineering, quality, or continuous improvement.
• 5+ years of leadership experience managing Quality or manufacturing teams within a production environment.
• Demonstrated success partnering directly with Manufacturing and Operations leadership to improve both quality and business performance.
• Demonstrated experience building, coaching, developing, and retaining high-performing teams and future leaders.
• Experience leading meaningful organizational, process, or cultural change within a manufacturing environment.
• Demonstrated experience leading investigations, CAPA, change control, deviation/nonconformance management, root cause analysis, and risk assessment.
• Experience implementing Lean Manufacturing, Six Sigma, PPI, or similar continuous improvement methodologies with measurable improvements in quality, efficiency, cost, delivery, or customer experience.
• Experience leading or supporting customer, regulatory, internal, or certification audits.
• Experience working within a Quality Management System in a regulated or highly controlled manufacturing environment.
• Strong understanding of manufacturing operations and Quality Management Systems.
• Strong working knowledge of regulated manufacturing requirements, including applicable FDA, GMP, ISO 9001, ISO 13485, and other relevant global quality standards.
• Demonstrated ability to make timely, risk-based decisions with incomplete or changing information while appropriately balancing customer, compliance, quality, and business requirements.
• Proven ability to build credibility and trust with Manufacturing and Operations and influence outcomes through relationships and collaboration rather than relying solely on authority.
• Strong understanding of CAPA, investigations, root cause analysis, change control, risk management, and continuous improvement.
• Experience with quality and engineering tools including FMEA, risk assessment, statistical analysis, process capability, and structured problem solving.
• Strong analytical capabilities with the ability to translate manufacturing and quality data into clear priorities and actionable improvements.
• Demonstrated ability to lead through ambiguity and change while maintaining organizational focus and engagement.
• Strong people-leadership capability with demonstrated success coaching, developing, challenging, and holding leaders and teams accountable.
• Ability to identify organizational capability gaps and build succession and development plans that prepare the Quality organization for future business needs.
• Strong executive presence with the ability to effectively communicate with operators, supervisors, engineers, customers, site leaders, divisional executives, and regulatory authorities.
• Ability to constructively challenge decisions while maintaining strong cross-functional relationships.
• Ability to simplify complex problems and translate regulatory or technical requirements into practical manufacturing solutions.
• Strong project management and organizational capabilities.
• Comfortable working in a fast-paced manufacturing environment with changing priorities and competing business demands.
• Experience using electronic Quality Management Systems (eQMS), manufacturing systems, and data-analysis tools.
• Willingness to maintain a strong presence within manufacturing operations and engage directly with employees at all organizational levels.
• 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 screening.

Nice To Haves

• Advanced degree is a plus.
• ASQ, Lean Six Sigma, or other recognized Quality or continuous improvement certifications are preferred.
• Pharmaceutical, medical device, biotechnology, diagnostics, life sciences, or other highly regulated manufacturing experience is preferred.
• Ability to travel up to 25%.

Responsibilities

• Lead, coach, and develop Quality Assurance and Quality Control teams supporting manufacturing operations, building capability, accountability, engagement, and a strong pipeline of future Quality leaders.
• Serve as the senior Quality partner to Manufacturing and Operations leadership, helping the site achieve quality, delivery, productivity, and customer objectives while maintaining appropriate compliance standards.
• Maintain a visible presence within manufacturing operations, working directly with employees, supervisors, engineers, and leaders to understand problems, remove barriers, and improve process performance.
• Make timely, pragmatic, risk-based quality decisions, balancing product quality, customer expectations, compliance requirements, manufacturing needs, and business priorities.
• Partner with Manufacturing, Engineering, Operations, Supply Chain, R&D, Commercial, and Technical teams to improve production processes, reduce risk, and drive sustainable improvements.
• Lead investigations, CAPA, change control, nonconformance, deviation, and root cause analysis activities with an emphasis on identifying systemic causes, implementing effective countermeasures, and preventing recurrence.
• Champion continuous improvement using Practical Process Improvement (PPI), Lean, Six Sigma, and structured problem-solving methodologies.
• Use quality and manufacturing data to identify trends, establish priorities, improve process capability, and drive fact-based decision-making.
• Partner with Engineering and Operations on process validation, equipment changes, technology transfers, process improvements, new product introduction, and manufacturing readiness.
• Ensure the site maintains a continuous state of inspection readiness and provide senior leadership during customer, regulatory, internal, and certification audits.
• Strengthen the Quality Management System while continually identifying opportunities to make quality processes simpler, faster, and more effective without compromising compliance or product quality.
• Build strong relationships with customers and commercial partners, particularly when managing complex quality, product, or delivery challenges.
• Lead organizational and cultural change that strengthens accountability, collaboration, quality ownership, and continuous improvement across the site.
• Develop Quality leaders and technical professionals through coaching, mentoring, meaningful development opportunities, succession planning, and clear performance expectations.
• Serve as an active member of the Divisional Quality & Regulatory Leadership Team, contributing to divisional strategy, priorities, governance, talent development, and continuous improvement.
• Represent the Marietta site within divisional Quality and Regulatory forums, ensuring site risks, opportunities, customer needs, and operational priorities are understood and appropriately addressed.
• Partner with Quality and Regulatory leaders across the division to share best practices, strengthen organizational capability, and drive appropriate consistency across sites.
• Translate divisional Quality and Regulatory priorities into practical site-level execution while ensuring site experience and operational realities help inform broader divisional strategy.

Benefits

• Opportunity to lead a Quality organization that directly impacts manufacturing performance, regulatory compliance, customer success, and the future capability of the Marietta site.
• Significant visibility and the opportunity to influence strategy beyond your immediate organization as a member of both the Site Leadership Team and the Divisional Quality & Regulatory Leadership Team.
• Opportunity to shape how Quality partners with the business across the broader division while bringing divisional capabilities, best practices, and resources back to the Marietta site.
• Opportunity to build a high-performing Quality organization, strengthen the partnership between Quality and Operations, develop the next generation of leaders, and create a culture where quality, compliance, customer experience, and operational excellence reinforce one another.
• Access to the resources and scale of a global life sciences leader while having a direct and visible impact on the performance and future of the Marietta operation.

What This Job Offers

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