The SCES Q manager at the CLIENT’S plant will 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 the CLIENT’S 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
- Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
- 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 the CLIENT 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
- 10+ years of experience working in a cGxP or other regulated
environment, with 3+ years of experience in a Quality role.
- This position will support the manufacturing operation in Allston, MA. Person needs to be on site