For our partner in the Canton of Neuchâtel, Gi Life Sciences is looking for a:
Associate Director Quality Control
Your mission:
This position is accountable for the Quality Control activities at an OSD drug product manufacturing site, including method transfer / verification, 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.
Duties:
- 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.
- 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 budget of the QC laboratory.
- Act as a backup for the commercial release activities (paper or within the LIMS).
Your Profile:
- University studies in chemistry, biochemistry, biology, or pharmacy or equivalent.
- >10 years' experience in OSD QC laboratory management, CMO advantageous
- Fluent in French and English.
- 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.
- Ability to take decisions based on scientific risk assessment, to reduce and control the risk of late-stage commercialization project operations.
- Able to manage, track and record budget.
