Overview
This position is accountable for the Quality Control activities at the OSD drug product manufacturing site of Couvet, Switzerland, including method transfer / verification, the analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing, as well as equipment cleaning residual testing and support the manufacturing related area operation such as environment monitoring. You will ensure activities meet cGMP requirements and customers’ expectations.
As the QC leader, you will be focused on the customers’ needs. You will mentor and coach your team, creating a strong team spirit. Using your significant experience, you will streamline QC processes and implement efficiencies.
This position is a strategic leadership role for the site and a role model for WuXi values and competencies.
Responsibilities
Essential Job Functions:
- Responsible for the 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.
- Accountable for meeting customers’ expectations and needs.
- Responsible for leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes.
- Responsible for reviewing and approving quality events (deviations, CAPA actions, OOX, CCR...).
- Accountable for optimizing QC processes, including procedures and daily operations to reduce lab errors and increase efficiency.
- Accountable for overviewing the daily management of the Quality Control team (planning, communication, team organization, control & feedback).
- Represent QC during client visits, audit and regulatory inspections as well as health authority audits.
- Responsible for QC medium- and long- term equipment and personnel planning
- Accountable for ensuring staff have adequate training to perform activities
- By collecting information and understanding facts to identify issues in the lab, draw correct and valid conclusions. Apply risk management tools to make decisions.
- Responsible for QC team talent development, including succession planning and career development.
- Be able to effectively oversee analytical processes based on production schedule.
- Responsible for budget of the QC laboratory.
- Act as a backup for the commercial release activities (paper or within the LIMS).
Qualifications
Experience / Education
- University studies in chemistry, biochemistry, biology, or pharmacy or equivalent.
- >10 years' experience in QC laboratory management, CMO advantageous
Knowledge / Skills / Abilities:
- Fluent in French and English.
- Autonomous and aptitude to work on the ground.
- Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer analysis, etc.
- Knowledge of electronic data lifecycle management in the laboratory to ensure data reliability and integrity.
- Familiar with method transfer and validation of drug products, material and product release as well as stability studies of drugs under different conditions.
- Familiar with laboratory investigation and establishment of corrective and preventive measures.
- Strong working knowledge to ensure quality control compliance with applicable regulations i.e. cGMP.
- Organized and rigorous, able to provide leadership and coaching to the QC team in order to maintain an environment of trust and personal accountability.
- Demonstrate ability to effectively communicate with the team and all levels of the organization. Work as a strong team partner in the site.
- Use of scientific risk assessment based on sufficient data to reduce and control the risk of late-stage commercialization project operations. Ability to make decision.
- Able to manage, track and record budget.
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