Senior Quality Leader - Manufacturing & Compliance

Regulatory Jobs; Logan (UT); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Quality improvements

Root cause analysis

CAPA

Risk management

Data analytics

Communication

Cross-functional collaboration

Audits & regulatory inspections

Problem solving

Education

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

Advanced degree preferred

Job description

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.