Director, Quality Control

Overview

This position is accountable for the overall Quality Control activities at the drug product manufacturing site of Couvet, Switzerland, including but not limited to method transfer / verification / validation, release of incoming materials and packaging components, in-process testing and release of drug product, stability study, as well as support of the manufacturing related area operation such as environment monitoring. You will ensure activities meet cGMP requirements and customers’ expectations.

As the QC head, you will be focused on the customers’ needs and execution of the company strategy. You will mentor and coach your team, creating a strong team spirit. Using your experience, you will streamline QC processes and implement efficiencies to ensure the quality and the on-time delivery

Essential Job Functions:

• Accountable for meeting customers’ expectations and needs
• Be responsible for making changes and improvement in QC based on deep analysis of the data to better meet business growth of the site.
• Responsible for the project management and lab management to ensure on-time and high-quality execution of all analytical activities in compliance with cGMPs.
• Accountable for QC process optimization, innovation introduction and staff training to reduce lab errors and increase efficiency.
• Responsible for providing enough QC support during client visits, audit and regulatory inspections.
• Responsible for QC equipment and personnel planning and management.
• Responsible for QC team talent development, including succession planning and career development. Accountable for ensuring staff have adequate training to perform activities.
• Responsible for budget management and capability establishment of the QC laboratory.
• Responsible for leading OOX investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes.
• Responsible for coordination of on-time trouble-shooting to ensure the project progress.

Experience / Education

• University studies in analytical chemistry, biochemistry, pharmacy or equivalent.
• >10 years' experience in QC laboratory management

Knowledge / Skills / Abilities:

• Fluent in English and French (preferably).
• Autonomous and aptitude to work on the ground.
• Solid knowledge of analytical technologies and laboratory workflows, such as HPLC and dissolution 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.