job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Saint Louis, Missouri
job type: Contract
salary: $39.38 - 46.33 per hour
work hours: 9 to 5
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.
- 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.
- 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.
- 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.
skills: Project Management, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.