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Thermo Fisher Scientific · 2 days ago
Director, QA, Global Deviation & CAPA Management
Massachusetts, United States
Full-time
Onsite
Director
10+ years exp
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Responsibilities
Ability to set clear direction and to effectively lead and manage a team.
Develop a strategy for Deviations & CAPAs in alignment with the business objectives.
Deviation and CAPA Business process owner within Global Quality Systems
Standardize and harmonize the quality system across all PSG sites.
Leads global quality improvements for deviation investigations and CAPAs including product complaints for a wide network of business units (drug substance large and small molecule, drug product, viral vector services, and clinical trials division).
Continuously support enhancement and improvement of the deviation management system.
Maintain oversight of deviation and CAPA quality including effectiveness checks
Support inspection readiness for deviations and CAPAs across all PSG sites.
Lead and support project alignment through the maintenance of policies and procedures, business review, trending, monitoring Key Performance Indicators, and inspections.
Lead and develop the certification program and trainings to improve site capabilities for all elements of investigations including data collection, report writing, root cause analysis, and CAPA management.
Maintain and continuously improve our Power BI dashboard to drive improvement.
Support the AI program to ensure that deviations are effectively addressed and that compliance with regulatory standards is maintained. This includes utilizing AI tools to identify and analyze deviations, providing guidance on appropriate CAPA actions, and ensuring that all necessary documentation and reporting is completed accurately and in a timely manner.
Qualification
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Required
Bachelor’s Degree or higher in Chemistry, Biochemistry, Engineering, or other physical science degrees with relevant work experience.
Minimum of 10 years’ experience in pharma/biopharma regulated industry (GxP) with strong direct hands-on pharmaceutical experience in deviation and CAPA management systems
Demonstrated leadership across functions and organizational levels.
Demonstrate the ability to incorporate sound risk management fundamentals
Embodies our Thermo Fisher values of Integrity, Involvement, Intensity, and Innovation.
Demonstrates excellent interpersonal verbal and written communication.
Six Sigma certified or Taproot RCA Certified Trainer is a plus
Project management skills for delegating data collection and coordination with SME
Strong verbal and written communication skills, with the discipline to document each phase of work.
Benefits
Healthcare
Annual Incentive Plan Bonus
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
