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Project Manager II (Clinical)


Location: Waltham, Massachusetts
Job Category:

Description:
Key Responsibilities may differ among employees with same job title and may change over time in
accordance with business needs.
Position Summary
The SCES Q manager Person in Plant acts as the day-to-day liaison with internal and external
customers for quality related activities.
• Ensure GMP compliance of products manufactured and/or tested at a contract facility.
• Ensure all aspects of product manufacturing and/or testing are reviewed versus established
quality standards and the applicable marketing authorizations.
• Manage Quality Systems, e.g. change control, deviations, complaints, and product investigations.
• Modify, review, and ensure contractor quality standards and protocols for processing materials
into partially finished or finished product meet Sanofi and GMP requirements.
• Contribute to the completion of milestones associated with specific projects.
Core Responsibilities
• Release product in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Implement methods and procedures for inspecting, testing, and evaluating the precision and
accuracy of products and production equipment.
• Compile data and write summaries for periodic product reviews, investigations, complaints, and
deviations.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable US and global regulations related to manufacture of
medicinal products (small molecules and biologics).
• Monitor contractor performance to established Key Performance Indicators (KPI) and report
adverse trends.
Additional Responsibilities
• May assist in vendor selection and evaluation.
• Provide QA project manager support for change controls and other projects.
• Develop and manage Quality Technical Agreements between Sanofi and the contractor
• Participate in contractor quality audits and verify any actions taken by the contractor in response
to audit observations are completed satisfactorily.
• Support program for maintaining performance metrics.
Basic qualifications are the minimum requirements that an individual needs to meet the needs to
meet the job description. The requirements need to be quantifiable (e.g., two years of project
management experience).
• Bachelor’s degree and 10+ years of experience working in a cGxP or other regulated
environment, with 3+ years of experience in a Quality role.

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