Director Global Quality Processes(m/w/x)

<p>Mainz, Germany | full time | Job ID: 8867 </p> <p>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.</p> <p>Your responsibilities: </p> <ul> <li>Lead the design, implementation and maintenance of core global quality processes within the One QMS compliant to international regulatory requirements and industry standards</li> <li>Strategically develop core quality processes linked to the company strategy </li> <li>Lead, develop and manage an international team based in Germany and the US by providing mentorship, development and succession planning</li> <li>Define performance measures for core quality processes to ensure data driven decision making</li> <li>Establish means to identify and mitigate quality-related risks linked to the global core processes</li> <li>Enable your team to identify and execute process improvements while ensuring regulatory compliance</li> <li>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</li> <li>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</li> </ul> <p>What you have to offer: </p> <ul> <li>University degree in Pharmacy, Chemistry, Biology, Biochemistry, Microbiology, Engineering or other related technical/scientific area</li> <li>Advanced degree (Ph.D., MBA) in a related field preferred</li> <li>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</li> <li>Refined colloquial and correspondence and moderator skills in German and English </li> <li>Knowledge in regulatory requirements including FDA, EMA, ICH</li> <li>Proven experience in developing and implementing global quality processes </li> <li>Excellent project management and organizational skills, with the ability to manage multiple priorities and deliver results in a fast-paced environment</li> </ul> <p><span style="color:#3c9673"><b>Your Benefits:</b></span></p> <p>It's our priority to support you:</p> <ul> <li>Your flexibility: flexible hours | vacation account </li> <li>Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning</li> <li>Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential</li> <li>Your health and lifestyle: Company bike</li> <li>Your mobility: Job ticket | Deutschlandticket </li> <li>Your life phases: Employer-funded pension | Childcare </li> </ul> <p>By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.</p>