QUALITY ASSURANCE MANAGER HF

Job description

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Quality Assurance Manager
- VIE Contract (W/M)
Job purpose:
We are looking for an energetic, reliable Quality Assurance Manager to ensure optimization of selected processes assuring that all external and internal requirements are met.
Your main mission will be to support Quality Assurance requests in the Diabetes and Biosynthesis Operations division (globally). You will be responsible for the implementation of novel and innovative process improvements, monitoring of progress to objectives and mitigation activities as needed, support for identified high risks at the supported facilities. You will conduct the implementation of Risk Management Program for Frankfurt Biotech in conjunction with plant team.
The ideal candidate is a reliable and competent professional whose approval will be necessary for the continuation of a business life cycle. Previous experience in GMP industry (Good Manufacturing Practice), together with some language skills (German and English) will help you to be successful in this role.
Main responsibilities:
- Implementation of the Sanofi Policies and Global Standard and Directives
- Inspection Readiness
- Risk identification and related remediation/mitigation
- Quality/GMP compliance projects
Tasks:
- Devising procedures to inspect and report quality issues
- Supporting and guiding inspectors, technicians and other staff
- Assuring the reliability and consistency of production by checking processes and final output
- Reporting relevant process challenges to leadership to ensure immediate action
- Facilitating proactive risk solutions by collecting and analysing quality data
- Reviewing current standards and policies
- Keeping records of quality reports, statistical reviews and relevant documentation
- Ensuring all legal standards are met
Requirements:
- Master’s degree in Biotechnology or equivalent
- at least 1 year experience in GMP industry (Good Manufacturing Practice), experience with ICH Q9 (Quality Risk Management) would be beneficial
- Fluent English
- min. intermediary German (B2) with a willingness to learn
- Able to work independently, well organised, good communication and presentation skills
- Thorough knowledge of methodologies of quality assurance and standards
- Excellent numerical skills and understanding of data analysis/statistical methods
- Good knowledge of MS Office and databases
- Great attention to detail and a results driven approach
- Excellent organizational and leadership abilities
- Reliable and Trustworthy