· The position holder is responsible to ensure that assigned Contract Manufacturing Organizations (CMO) with assigned products comply with the relevant quality systems and abide the contractual obligations of the contract.
· Compilation of Change Control requests and coordination of CMC documenation in agreement with the CMO and 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
· Review and monitoring of deviations, OOS reports, and CAPAs by target setting, as well as compilation of risks in the risk management tool
· Initiation and monitoring of stability programs
· 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
· Diploma/Masters degree in Pharmaceutics or Natural Sciences, Ph.D. preferred
· Minimum of 3 years experience in pharmaceutical industry, preferably in quality, production environment or surveillance of CMOs/suppliers
· Strong knowledge of pharmaceutical regulations/national and international GMPs (incl. EU and FDA)/GDP, preferably experience in project work
· Excellent oral and written communication skills and fluent in German and English
· Analytical and structured way of thinking, strong communication and team skills, high sense of responsibility, and ability to clarify complex situations
· Experience with international teams, intercultural competence, confident presence in negotiations and taking pleasure in networking
· Assertiveness, result-oriented work style with a sense of priority and urgency
· Willingness for occasional business trips
· Fluent in English
· 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.