Mainz Associate Director CTSM, Supply Integration & Integrity RP 55116

Job description

Mainz, Germany | full time | Job ID: 11841 About The Role: The Associate Director CTSM Supply Integration & Integrity oversees the integration of information and ensures Clinical Trial Supply Management function complies with regulatory standards. This role is pivotal in enabling IMPM and other CTSM functions in optimizing information processes and ensuring seamless flow and accuracy of information across clinical trials and externals. Your Contribution: Enable IMPMs and other CTSM functions to ensure Clinical Trial Supply Management is audit and inspection ready Act as CTSM Audit and Inspection Finding Owner Enable IMPMs and other CTSM functions addressing clinical trial supply management findings, and implementing corrective and preventive actions (CAPAs) Oversee and support addressing clinical trial supply management processes, findings and implementing corrective and preventive actions (CAPAs) Owns the CTSM issue management, root cause analysis and efficient lessons learned processes. Maintain dashboard supporting the above listed tasks and decision making Owning, organizing and driving projects enabling CTSM Oversee CTSM TMF index, own CTSM filing strategy in alignment with Global Development Excellence and conduct TMF index updates in CTSM Enable IMPMs and other CTSM functions in filing required documentation (e.g. in the Trial Master File and repositories owned by CTSM) Lead and oversee CTSM Sponsor Oversight strategy Enables IMPMs and other CTSM functions to deliver records in time (e.g. Deviations, Change Controls) Support harmonization and simplification on the above-described activities; ensure efforts are in alignment with gaining efficiency and remaining required flexibility Act as CTSM Single Point of Contact (SPOC) and Inspection Support Team (IST) representative for Audits and Inspections e.g. by coordinating in CTSM consolidated preparation and responses to requests prior handover to QA for quality check Support on One Corporate GxP QMS topics Act as CTSM QAA Spoc A Good Match: Relevant completed university education in Engineering, Supply Chain Management, Quality Management, or related discipline Broad and/or in-depth and special task-specific expertise and skills (doctorate, if applicable) Relevant professional experience (usually +5 years) in Clinical Trial Supply Management, Pharmaceutical or Biotech or any other equivalent regulated industry setting Proven Audit and/or Inspection relevant certificates or qualifications surplus Proven track record in preparation and participation of audits and inspections Deep Quality Management System Knowledge, GMP principles (e.g., SOPs, Process Controls, etc.) and GCP principles (e.g., Ethical principles, Adequate Drug Information, etc.) Advanced experience in dealing with agencies/authorities e.g., FDA, EMA, BSI, etc. Experience in latest planning tools (e.g., Microsoft Project) and standard office software proficiency (e.g., MS Office) Excellent Project Management Skills and business-professional English language skills Decision making skills based on experiential knowledge, paired with strategic thinking and negotiation skills Ability to solve multi-layered and dynamic tasks in flexible and changing framework conditions Ability to create independent analyses and develop new solutions as well as derive or elaborate suitable next steps Assertiveness and strong communication skills as well as service mentality - stakeholder management on eye level Ability to lead various individuals of different professional backgrounds and expertise levels, with resilience to constantly changing work environment Assertive, with the confidence to be a voice of authority - eager to do what is best for the team and openness to explore new topics/trends Your Benefits: Company Pension Scheme Childcare Jobticket Company Bike Special Vacation ... and much more. Apply now - We look forward to receiving 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) 6781 9855 220. Job ID 11841 (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