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Quality Business Owner
| Company | Sanofi |
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| Location | Framingham, MA, USA |
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| Salary | $108750 – $157083.33 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree in science or a relevant field – required.
- 5+ years of experience in quality or manufacturing with deviations and CAPA management within the pharmaceutical/biotech industry – required.
- Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement (using PowerBI and Excel).
- Strong verbal and written communication skills with the ability to work collaboratively with others.
Responsibilities
- Conducting routine data quality checks and validations to identify and address any process, system or data issue.
- Developing and delivering training programs, principles and best practices.
- Identifying and assessing risks and implementing mitigation strategies.
- Leading continuous improvement initiatives on-site in line with global processes and practices.
- Overseeing the computerized systems associated to ensure they meet all requirements.
- Establishing and monitoring key performance indicators in line with global guidance.
- Being representative of the site in the CoP and if requested participating in the CoE while ensuring local communication.
- Representing Sanofi global quality when interacting with health authorities for global processes.
- Responsible for overseeing overall QMS health at the Mass BioCampus facilities to ensure quality and compliance.
- Responsible for timely compilation of data for, and compliance to the procedures that govern Quarterly Management Reviews, Product Quality Reviews, Site Quality Council, Site Risk Profile, and investigation system maintenance for site needs.
Preferred Qualifications
- Experience with change controls and complaints – preferred.
- Experience working with global partners is preferred.
