Senior Manager, Quality

Regulatory Toolkit; Logan (UT); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Manager, Quality for BEA and Flexible Operations at the Logan, UT site. Lead the site quality organization, ensure regulatory compliance, and drive continuous improvement across manufacturing processes supporting flexible single-use technologies.

You will partner with operations, engineering, supply chain, regulatory affairs, and site leadership to foster accountability and customer focus.

Formación

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality, or related technical discipline required.
• Advanced degree preferred.
• 8+ years of progressive quality experience within regulated manufacturing environments.
• 3+ years of leadership experience managing quality teams.
• Experience in medical device, bioprocessing, pharmaceutical, life sciences, or single-use manufacturing environments preferred.
• Strong knowledge of quality systems and regulatory requirements including ISO 9001, ISO 13485, GMP, and FDA regulations.

Responsabilidades

• Lead and develop the site quality organization supporting BEA and Flexible Operations manufacturing activities.
• Establish and maintain a strong quality culture focused on compliance, operational excellence, and continuous improvement.
• Serve as a key member of the Logan site leadership team, contributing to strategic and operational decision-making.
• Drive accountability through quality metrics, performance management, and development planning.
• Mentor and coach quality leaders and team members to build organizational capability.
• Ensure site compliance with applicable global regulatory requirements, industry standards, and internal quality management systems.
• Maintain site inspection readiness, including support for audits.
• Oversee effectiveness of Flexible site quality systems including CAPA, Change control, Nonconformance management, Complaint handling, Document control, Training compliance, Risk management and Validation activities.
• Drive timely and effective investigations, root cause analysis and corrective actions.
• Support implementation and harmonization of divisional quality initiatives and procedures.
• Partner cross functionally to reduce cost of poor quality and improve operational efficiency.
• Utilize data analytics and quality metrics to identify trends, risks, and improvement opportunities.
• Support product transfers, capacity expansions, and new product introductions
• Ensure robust investigation practices and timely resolution of deviations and customer concerns.
• Build strong customer relationships through responsiveness, transparency, and quality performance.

Conocimientos

Leadership

Quality improvements

Root cause analysis

CAPA

Risk management

Data analytics

Communication

Cross-functional collaboration

Audits & regulatory inspections

Problem solving

Educación

Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality, or related technical discipline

Advanced degree preferred

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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, like protecting the environment, making sure our food is safe or helping find cures for cancer.

LOCATION

On-site Logan, UT.

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

POSITION SUMMARY

The Senior Manager, Quality for BEA and Flexible Operations at the Logan, Utah site is responsible for leading site quality operations and ensuring compliance, product quality, and continuous improvement across manufacturing processes supporting flexible single-use technologies and products. This role partners closely with Operations, Engineering, Supply Chain, Regulatory Affairs, and site leadership to drive operational excellence, maintain regulatory compliance, and support business growth.

The Senior Manager, Quality will lead quality teams responsible for manufacturing quality, quality systems, and customer quality activities while fostering a strong culture of accountability, continuous improvement, and customer focus.

WHAT YOU WILL DO

Site Quality Leadership

• Lead and develop the site quality organization supporting BEA and Flexible Operations manufacturing activities.
• Establish and maintain a strong quality culture focused on compliance, operational excellence, and continuous improvement.
• Serve as a key member of the Logan site leadership team, contributing to strategic and operational decision-making.
• Drive accountability through quality metrics, performance management, and development planning.
• Mentor and coach quality leaders and team members to build organizational capability.

Quality Systems

• Ensure site compliance with applicable global regulatory requirements, industry standards, and internal quality management systems.
• Maintain site inspection readiness, including support for customer, notified body, and regulatory agency audits.
• Oversee effectiveness of Flexible site quality systems including: CAPA, Change control, Nonconformance management, Complaint handling, Document control, Training compliance, Risk management and Validation activities
• Drive timely and effective investigations, root cause analysis and corrective actions.
• Support implementation and harmonization of divisional quality initiatives and procedures.

Operational Quality Support

• Partner cross functionally to reduce cost of poor quality and improve operational efficiency.
• Utilize data analytics and quality metrics to identify trends, risks, and improvement opportunities.
• Support product transfers, capacity expansions, and new product introductions
• Ensure robust investigation practices and timely resolution of deviations and customer concerns.
• Build strong customer relationships through responsiveness, transparency, and quality performance.

HOW YOU WILL GET HERE

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality, or related technical discipline required
• Advanced degree preferred
• 8+ years of progressive quality experience within regulated manufacturing environments
• 3+ years of leadership experience managing quality teams
• Experience in medical device, bioprocessing, pharmaceutical, life sciences, or single-use manufacturing environments preferred
• Strong knowledge of quality systems and regulatory requirements including ISO 9001, ISO 13485, GMP, and FDA regulations

Technical & Leadership Competencies

• Strong leadership and team development capabilities
• Proven ability to drive quality improvements in manufacturing environments
• Expertise in root cause analysis, CAPA, risk management, and quality systems
• Strong analytical and problem-solving skills
• Excellent communication and cross-functional collaboration skills
• Ability to influence and build strong partnerships across functions
• Experience supporting audits and regulatory inspections
• Demonstrated ability to manage multiple priorities in a fast-paced environment

Key Success Metrics

• Audit outcomes
• Reduction in nonconformance and quality events
• CAPA effectiveness and closure timeliness
• Customer complaint reduction and responsiveness
• Employee engagement and talent development
• Continuous improvement and cost reduction results

Leadership Expectations

• Demonstrate integrity, accountability and customer focus
• Lead through collaboration, communication and empowerment
• Foster a culture of quality, safety and continuous improvement
• Operate effectively in a fast-paced, matrixed, global organization
• Displays the Thermo Fisher 4i values of Innovation, Integrity, Intensity and Involvement

Travel Requirements

• Travel up to 10% as required for business support, training and collaboration across sites

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company 401k, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.