Description de l'offre
· The position holder is responsible to ensure that effective Quality standards are followed at the interface to assigned Contract Manufacturing Organizations (CMO) with assigned products and that CMOs comply with the relevant current GMPs, GDPs, relevant regulatory requirements and internal Sanofi standards and abide the contractual obligations of the contract
· Verification of regulatory compliance by compilation and assessment of Change Control requests, coordination of the creation of CMC documentation in agreement with the CMO and Regulatory Affairs in the function as Regulatory Site Officer (RSO) in Phenix Change Control; coordination of renewals with CMO and Global Regulatory Affairs
· Support of life cycle management projects, e.g. Product Design Reviews (PDR); and as Team Member Quality in launch projects for established CMOs
· Compilation and evaluation of Product Quality Reviews
· Driving continuous improvement and CAPA processes at the CMOs through target setting, assessment and monitoring of deviations, OOS reports, CMO rating, support in the assessment of complaints
· Maintenance of product risk oversight (e.g. evaluation of PQRs, monitoring of stability data, stability protocols, validation protocols and reports) and driving proactively risk reduction programs (Risk Management, Product design review, regulatory compliance check)
· Contribution to contract negotiations with special focus on Quality Assurance Agreements
· Involvement in process and analytical validations incl. evaluation and approval of related documentation, and assistance within transfer processes
· Contribution to and participation in quality meetings and audits at the CMO
Requirements & Qualifications
· Academic with several years practical experience in QA and/ or production or QC as well as Project Management. Diploma/Master degree in Pharmaceutics or Natural Sciences, Ph.D. is a plus
· Minimum of 2 -3 of practical experience in pharmaceutical industry in GMP environment (Quality Assurance and Development or Production / QC). Experience in establishing and maintaining GMP and regulatory compliance
· Know-how of contractual manufacturing topics is a plus
· Knowledge of national and international current drug GMPs/GDPs (incl. EU, FDA). Due to the complexity of the product portfolio additional practical knowledge in food, medical device, cosmetic regulations is favorable
· Demonstrates a commitment to Quality in all activities, sets goals for standards. Good knowledge about Quality systems and Quality management systems, both required at Sanofi and applicable regulations (e.g. medicinal products).
· Strong oral and written communication skills and interpersonal skills in international environment.
· Capability in dealing with complexity (due to high number of projects / CMOs / Product Composition Identities (PCID) / product categories).
· Willingness for occasional business trips
· Excellent oral and written communication skills and fluent in German and English. Any language skills in addition to German and English are preferred
· An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
· An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
· An individual and well-structured introduction and training of new employees.
· You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
· As a globally successful and constantly growing company, Sanofi provides international career paths as well.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize that to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.