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Quality Management Director
vor 2 Wochen
We are seeking an experienced Associate Director Quality Control to join our team at our OSD drug product manufacturing site in Couvet, Switzerland. The successful candidate will be responsible for the overall quality strategy and operations at the site, ensuring that all activities meet cGMP requirements and customers' expectations.
This is a strategic leadership role for the site and a role model for WuXi values and competencies. As a leader, you will mentor and coach your team, creating a strong team spirit. Using your significant experience, you will streamline QC processes and implement efficiencies.
The Associate Director Quality Control will be accountable for project management, customer satisfaction, quality event review and approval, process optimization, and team management.
Key Responsibilities:- Project management to ensure on-time and high-quality execution of analytical activities, including method transfer/verification and all testing, in compliance with the site's Quality Management Systems (QMS) & cGMPs.
- Meeting customers' expectations and needs.
- Leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes.
- Reviewing and approving quality events (deviations, CAPA actions, OOX, CCR...).
- Optimizing QC processes, including procedures and daily operations to reduce lab errors and increase efficiency.
- Overseeing the daily management of the Quality Control team (planning, communication, team organization, control & feedback).
- Representing QC during client visits, audit and regulatory inspections as well as health authority audits.
- QC medium- and long-term equipment and personnel planning.
- Ensuring staff have adequate training to perform activities.
- Collecting information and understanding facts to identify issues in the lab, draw correct and valid conclusions. Applying risk management tools to make decisions.
- QC team talent development, including succession planning and career development.