Director Global Quality Processes
Mainz, Germany | full time | Job ID:8867
As Director of Global Quality Processes, you will be part of BioNTech´s Global Systems Quality Team. You will be accountable to ensure that core quality processes like Document Management, Trainings, Issue Management or Change Control meet regulatory requirements and will be stepwise globalized into One QMS. You will lead an international team responsible for standardizing, maintaining and continuously improving those processes as well as the related eQMS utilized. You will collaborate across different functions within the company and this position requires international work across EU, US and partially also Asian time zones.
Lead the design, implementation and maintenance of core global quality processes within the One QMS compliant to international regulatory requirements and industry standards
Strategically develop core quality processes linked to the company strategy
Lead, develop and manage an international team based in Germany and the US by providing mentorship, development and succession planning
Define performance measures for core quality processes to ensure data driven decision making
Establish means to identify and mitigate quality-related risks linked to the global core processes
Enable your team to identify and execute process improvements while ensuring regulatory compliance
Ensure audit and inspection readiness, provide required oversight and support for regulatory inspections and internal audits and ensure resolution of findings with your area of responsibility
Foster strong partnerships across various functions, collaborate cross-functionally (eg. Development, Manufacturing, Supply Chain, CMC, Reg. Affairs and others) to integrate core quality process into the business while ensuring alignment and buy-in
University degree in Pharmacy, Chemistry, Biology, Biochemistry, Microbiology, Engineering or other related technical/scientific area
Advanced degree (Ph.D., MBA) in a related field preferred
Minimum of >10 years of work experience in manufacturing, quality control, quality assurance, or other relevant area, in a biotech or pharmaceutical company with at least 5 years in a leadership role and experience in overseeing global teams
Refined colloquial and correspondence and moderator skills in German and English
Knowledge in regulatory requirements including FDA, EMA, ICH
Proven experience in developing and implementing global quality processes
Excellent project management and organizational skills, with the ability to manage multiple priorities and deliver results in a fast-paced environment
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare