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Thermo Fisher Scientific · 3 days ago
Compliance Director
Massachusetts, United States
Full-time
Onsite
Director
15+ years exp
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Responsibilities
Identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites.
Prepare detailed audit reports to communicate observations in a meaningful and accurate way.
Maintain knowledge of GMPs and stay aware of revised or emerging quality regulations and industry methodologies globally.
Promote positive Quality and leadership behaviors within the organization.
Participate in ad-hoc quality compliance projects related to auditing.
Holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via an independent audit program.
Help minimize risk across sites and achieve successful regulatory inspections.
Contribute towards the success of PSG and the services/products provided to clients and patients.
Qualification
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Required
Bachelor’s Degree in Pharmacy, Science or Engineering
Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience
At least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections
Must be an expert Quality compliance auditor
Experience with elements of data integrity in pharmaceutical manufacturing environment
Skilled in quality investigations, root cause analysis, audit reporting, and benchmark sharing
Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ)
Strong foundation of pharmaceutical manufacturing and laboratory operations
Diverse experience auditing a wide range of manufacturing technologies and services in specified areas
May be required to support other VVS MA sites as needed
Preferred
Advanced degree in related field
Experience in sterile manufacturing and aseptic practice
40-50% travel based on business needs
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
