Mainz Senior Director Global Quality Inspection Preparedness And Compliance Excellence RP 55116

Job description

Mainz, Germany | full time | Job ID: 11850 About the Job: In this global leadership role, you will drive enterprise-wide inspection preparedness and strengthen BioNTech auditor capabilities required for internal as well as external audits. You will advance GxP compliance maturity and help ensure sustained inspection readiness. Your Contribution: Lead the global GMP compliance program, advising cross-functional teams on regulatory expectations and emerging trends. Define and drive the inspection readiness framework, standards and roadmap for internal sites and CDMOs. Lead cross-functional readiness programs and mock inspections; assess gaps, define remediation plans and track implementation to maintain a consistent state of control ahead of authority inspections. Establish and oversee the global auditor excellence framework, including auditor selection, qualification and performance oversight. Ensure consistent audit practices, tools, standards and performance measures. Advance auditor excellence through strategic development initiatives, project assignments, shadowing and training programs. Ensure compliance training requirements are met and build world-class audit and inspection expertise. Establish and oversee the CDMO inspection readiness framework, including audit planning, findings management and escalation. Implement risk-based scoring and preventive measures to proactively reduce quality and supply chain risks. A Good Match: You hold an advanced degree in life sciences or pharmacy. You bring extensive GxP experience and a strong track record of supporting and leading health authority inspections. You have in-depth expertise in global quality systems (10+ years) and you can translate regulatory expectations into practical, effective approaches across a complex organization. You have a proven track record in CDMO oversight, including the ability to strengthen inspection readiness and proactively address quality and supply chain risks. You are an excellent stakeholder manager who builds trusted relationships and works effectively across functions, sites and external partners. You communicate confidently in English and can engage clearly with stakeholders at all levels. Your Benefits: 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 Apply now - We look forward to your application! Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET). Job ID 11850 (please always specify if you have any questions) 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. Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed. * Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you www.biontech.com Apply now » Find similar jobs: Alle Stellen, All Jobs Terms of Use General Terms and Conditions Data Privacy Statement Imprint Cookie Settings © 2024 BioNTech SE. All rights reserved Cookie Consent Manager We use cookies to give you the best possible website experience. Your cookie settings are stored in the local memory of your browser. These include cookies that are absolutely necessary for the operation of the website and additional cookies for a more convenient use of the website or for personalized content. You can decide at any time whether you want to accept or reject these additional cookies. If you do not accept all cookies, your experience with the website and services may be impaired. Further information can be found in our Privacy Statement and Cookie Statement . Necessary cookies These cookies are required to use this website and can't be turned off. Necessary cookies Necessary cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Functional Cookies These cookies provide a better customer experience on this site, such as by remembering your login details, optimizing video performance, or providing us with information about how our site is used. You may freely choose to accept or decline these cookies at any time. Note that certain functionalities that these third-parties make available may be impacted if you do not accept these cookies. Consent to all Functional Cookies Functional Cookies Provider Description Enabled YouTube YouTube is a video-sharing service where users can create their own profile, upload videos, watch, like, and comment on videos. Opting out of YouTube cookies will disable your ability to watch or interact with YouTube videos. Cookie Policy Privacy Policy Terms and Conditions Consent to cookies from provider YouTube