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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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ThermoFisher Scientific
Senior Manager, Quality
Career Insights for Clinical Quality Manager
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Based on Utah data
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What they do
A Clinical Quality Manager ensures that the quality of the work in a clinical environment is consistent and meets government and industry standards as well as customer expectations. Verifies compliance with health and safety regulations. Coordinates all activities related to quality assurance and monitoring and revises existing processes in order to increase efficiency.
$125,929 / year median in Utah
Job Description
- 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.
LOCATION
- : On-site Logan, UT. Relocation assistance is NOT provided. + 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.
WHAT YOU WILL DO
Site Quality Leadership:
- + Lead and develop the site quality organization supporting BEA and Flexible Operations manufacturing activities.
Quality Systems:
- + Ensure site compliance with applicable global regulatory requirements, industry standards, and internal quality management systems.
Operational Quality Support:
- + Partner cross functionally to reduce cost of poor quality and improve operational efficiency.
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 regulationsTechnical & 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 is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.