In the context of the set-up of a new software application for the management of the company Quality System, we are seeking a quality assurance/control manager in charge of our pharmaceutical and clinical development activities (processes, indicators, audits, trainings, etc.) to collaborate with the Quality Manager dedicated to the research activities.
- In collaboration with the Quality Manager in charge of the research activities, implementation and follow up of the Global Quality Policy and Quality Management System
- Subcontractors qualification (CMO, CRO, raw material and packaging articles suppliers, storage and distribution) and follow up
- Complaints, Change Control, CAPAs, deviations and non-conformity follow up
- Quality control of data and reports of the clinical trial applications: TMF, IMPD and IB review
- Documentation management and quality control (Quality Manual, SOP, Methods, Specifications, Manufacturing instructions, batch record)
- Maintain the internal process in compliance with company referential or requirement specifications
- Evaluate the consequences of technical alterations in terms of quality (organization, documentation, validation, training, etc.)
- Evaluate the deviation’s critical aspect and process major malfunctions
- Risk analysis and associated action plan
- Maintain professional relations with public authorities and answer interrogations regarding quality audits.
- Set-up, approval and follow up on quality assurance contracts, manufacturing and supply agreements with various partners and/or pharmaceutical companies
- Approve and follow up on internal and external audits (suppliers)
- Contribute on quality topics to external due diligences from existing or future partners
- Maintain technological and reglementary intelligence
Master degree level training in Science/Biotechnology with a specialty in quality assurance
At least 5 years field experience in a quality assurance department of a research company or organism.
You have an experience with GLP, GCP and/or GMP systems.
Self-reliant, thorough and dynamic, you are a driving force of improvement in the company as you interact transversally with all departments and throughout interactions with external partners.
You have excellent interpersonal skills; you know how to advise while remaining decisive to maintain quality levels.