Location: Villepinte (93), France
Guerbet is recruiting a Global Sterility & Microbiology Quality Assurance Manager M / F on a permanent contract, reporting to the Quality Director of the Group’s Technical Operations / Head of Pharmacy.
As the Sterility & Microbiology Quality Assurance Manager M / F of the Group, you will be responsible for providing leadership and direction of microbiological testing, the microbiology laboratory and related subjects of sterile manufacturing for the assigned subjects.
You will lead the development, deployment and maintenance of quality standards or SOPs for multiple divisions to ensure that Guerbet’s technical operations are cGMP compliant for these topics.
You will also be the point of contact for sterility assurance and quality assurance in microbiology for several sites in the Guerbet network.
Main missions
As head of sterility and microbiology quality assurance, you will be responsible for:
– Lead the contamination control strategy and the EM group program
– Supervise sterilization processes, participate in quality risk assessments and improvement programs
– Conduct major investigations on issues impacting sterility assurance (i.e. unfavorable trends in ME …)
– Review and approve any major / critical deviation and any proposed change that has an impact on sterility assurance
– Act as SME for the introduction of new products and for applicable investment projects
– Audit sterile sites and suppliers providing microbiological service or sterile materials
– Develop, write and maintain the quality standards of the division in accordance with regulatory requirements and GMP expectations
– Subject Matter Expert (SME) who can support quality decisions related to sterility failures, OOS and in general deviations from the sterilization process
– Monitoring of measures for QTO network sites in order to comply with division standards, if applicable
– Provide support to Regulatory Affairs when questions are asked by regulators during the review of files
– Represent Guerbet in external forums, conferences and working groups such as A3P, SFSTP, ISPE, PDA, EP or USP
– Understand compliance gaps and quality improvement objectives for microbiology topics
– Work with sites to ensure consistency and alignment of microbiology topics
– Ensure the implementation of CAPA continuous improvement linked to sterile site practices
– Participate, if necessary, in the management of change requests on the site, which may affect the sterility of the site or the product
– Transform compliance and / or quality for subjects of microbiology and sterile practices in manufacturing areas and laboratories (dressing practices, environmental monitoring, etc.)
– Understand and / or influence regulatory or industrial standards
– Provide expertise and support to sites regarding regulatory inspections
– Develop responses to inspection observations, important investigations and advice on CAPA
Desired skills / experience
– Holder of a Master and / or Ph.D. in microbiology, biochemical engineering, or equivalent
– 10 years of experience in the pharmaceutical, biopharmaceutical or medical device industry
– Expertise in microbiological laboratory, microbiological tests and sterile good practices
– Knowledge of pharmacopoeias (USP, EP, JP) and ISO industry standards
– Mastery of international GMP and regulatory quality requirements (ANSM, FDA, EMA, TGA, ANVISA, HPRA, KFDA, PMDA)
– Experience in inspection and regulatory responses
– English written and spoken fluently
You listen, know how to deal with a variety of information and are able to develop solutions and defend a position.
With good communication and a good team spirit, do not hesitate to apply!
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