Senior Quality Manager: Manufacturing & Compliance

RXinsider LTD.; Logan, Northern (UT, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual incentive plan bonus

Healthcare

Company 401k

Employee benefits

Job summary

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

You will mentor quality leaders and partner with Operations, Engineering, and Regulatory Affairs to support business growth.

Qualifications

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

Responsibilities

• Lead site quality organization for BEA and Flexible Operations manufacturing.
• Ensure compliance, product quality, and continuous improvement across processes.
• Oversee quality systems including CAPA, change control, nonconformance, and audits.
• Drive investigations, root-cause analysis, and corrective actions.
• Partner cross-functionally to reduce cost of poor quality and improve efficiency.
• Support product transfers, capacity expansions and new product introductions.

Skills

Leadership

Quality improvements

Data analytics

Root cause analysis

CAPA

Risk management

Cross-functional collaboration

Communication

Audit support

Prioritization

Education

Bachelor’s degree in Engineering/Life Sciences/Chemistry/Quality

Advanced degree preferred

Tools

Quality management systems

Job description

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

You will mentor quality leaders and partner with Operations, Engineering, and Regulatory Affairs to support business growth.