Senior Manager, Quality

Thermo Fisher Scientific seeks a Senior Manager, Quality to lead quality operations at the Logan, Utah site, overseeing manufacturing compliance, quality systems, and continuous improvement for flexible single-use technologies. The role requires site leadership, regulatory expertise, and cross-functional partnership to drive operational excellence and business growth.

Responsibilities

• Lead site quality organization and establish culture of compliance, operational excellence, and continuous improvement
• Ensure regulatory compliance with global requirements and maintain inspection readiness for audits
• Oversee quality systems including CAPA, change control, nonconformance management, and validation activities
• Partner cross-functionally to reduce cost of poor quality and identify improvement opportunities
• Mentor quality leaders and manage performance through metrics and development planning

Requirements

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Quality, or related technical discipline
• 8+ years progressive quality experience in regulated manufacturing environments
• 3+ years leadership experience managing quality teams
• Strong knowledge of ISO 9001, ISO 13485, GMP, and FDA regulations
• Experience in medical device, bioprocessing, pharmaceutical, or single-use manufacturing preferred
• Root cause analysis, CAPA, and risk management expertise
• Ability to manage multiple priorities in fast-paced, matrixed environments