Sr Quality Manager

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Senior Quality Manager

Location: Marietta, Ohio, United States of America

*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.

Work Schedule: Standard (Monday–Friday)
Travel: Up to 25%

Make an Impact Through Manufacturing Excellence

At Thermo Fisher Scientific, your work directly contributes to helping customers make the world healthier, cleaner, and safer. As part of a global organization with more than $40 billion in revenue and the industry's largest investment in R&D, you'll have the opportunity to lead meaningful quality initiatives, collaborate with talented manufacturing and engineering teams, and drive continuous improvement across a growing operation.

We're looking for 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 how the site operates.

If you're passionate about developing people, improving manufacturing processes, making sound risk-based decisions, and creating a culture where Quality and Operations succeed together, we'd like to hear from you.

Discover Impactful Work

As the Senior Manager, Quality, you will be a key member of both the Marietta Site Leadership Team and the Divisional Quality & Regulatory Leadership Team. Beyond the Marietta site, you will collaborate with divisional Quality and Regulatory leaders to shape strategy, strengthen organizational capability, share best practices, and drive consistent standards and continuous improvement across the broader division.

What You'll Do

• 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.

Minimum Qualifications

Education

• Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Life Sciences, Chemistry, or another related technical discipline.

• Advanced degree is a plus.

• ASQ, Lean Six Sigma, or other recognized Quality or continuous improvement certifications are preferred.

Experience

• 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.

• Pharmaceutical, medical device, biotechnology, diagnostics, life sciences, or other highly regulated manufacturing experience is preferred.

Knowledge, Skills & Abilities

• 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.

• Ability to travel up to 25%.

The Leader We're Looking For

The successful candidate will be more than an experienced Quality professional. We're looking for someone who can lead a business through Quality.

You will:

• Build trust with Operations and be viewed as a partner rather than a gatekeeper.

• Listen and understand before making significant organizational or process changes.

• Be visible, approachable, and engaged with employees on the manufacturing floor.

• Make decisions at the appropriate speed using available data, experience, and sound risk judgment.

• Know when additional information is necessary—and when the organization needs a decision.

• Challenge constructively and be comfortable having difficult conversations.

• Create accountability without creating a culture of fear.

• Develop people rather than becoming the person who personally solves every problem.

• Identify and develop future leaders before positions become vacant.

• Simplify processes where possible without compromising compliance, product quality, or customer expectations.

• Use data and direct observation to distinguish symptoms from root causes.

• Remain calm, credible, and decisive during customer, regulatory, and operational escalations.

• Think beyond today's challenges and build an organization capable of supporting the site's future.

What Success Looks Like

During your first 12–18 months, success will include:

• Establishing strong, trusted working relationships between Quality, Operations, Engineering, and the broader site leadership team.

• Building a high-performing Quality organization with clear roles, expectations, accountability, development plans, and succession.

• Increasing Quality's visibility and engagement within manufacturing operations.

• Improving the quality, effectiveness, and timeliness of investigations, CAPAs, change controls, and quality decisions.

• Reducing recurring quality issues through stronger root cause analysis, risk management, and preventive action.

• Establishing meaningful leading and lagging quality indicators that enable earlier identification of emerging risks.

• Improving manufacturing quality and process capability while maintaining regulatory compliance and inspection readiness.

• Strengthening customer confidence through responsive, transparent, and effective resolution of quality issues.

• Demonstrating measurable improvement in quality, operational performance, and customer experience.

• Building stronger leadership capability and succession within the Quality organization.

• Establishing effective relationships across the Divisional Quality & Regulatory Leadership Team and contributing meaningfully to divisional strategy and improvement initiatives.

• Creating a sustainable culture where Quality and Operations share ownership for product quality and business performance.

Why Join Thermo Fisher Scientific?

You'll have the opportunity to lead a Quality organization that directly impacts manufacturing performance, regulatory compliance, customer success, and the future capability of the Marietta site.

As a member of both the Site Leadership Team and the Divisional Quality & Regulatory Leadership Team, you will have significant visibility and the opportunity to influence strategy beyond your immediate organization.

You will help shape how Quality partners with the business across the broader division while bringing divisional capabilities, best practices, and resources back to the Marietta site.

This is an 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.

At Thermo Fisher Scientific, you'll have 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.