Senior Manager, Quality

Thermo Fisher Scientific•Logan, UT

7d•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality, or related technical discipline required
8+ years of progressive quality experience within regulated manufacturing environments
3+ years of leadership experience managing quality teams
Strong knowledge of quality systems and regulatory requirements including ISO 9001, ISO 13485, GMP, and FDA regulations
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
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.

Nice To Haves

Advanced degree preferred
Experience in medical device, bioprocessing, pharmaceutical, life sciences, or single-use manufacturing environments preferred

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 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.
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.