Shanghai ITBP Site IT Leader Nantong SH 200050

Job description

Nantong, China | full time | Job ID: 11727 About the role: As IT Lead for Manufacturing and Quality in Nantong, you' ll connect site operations with digital solutions that support reliable, compliant biopharmaceutical manufacturing. Your work will help BioNTech advance its mission to develop innovative immunotherapies.Partner with teams across the site and with IT colleagues in China and Germany. You' ll guide projects and systems in a growing, GxP-regulated environment, helping align technology with business needs and global IT strategy. Your contribution: Act as the IT site leader and partner with Nantong site all functions. Identify digitalization needs, provide technical solution consulting and ensure key systems align with business objectives. Drive system optimization. Lead the full lifecycle of IT projects supporting the fast growing business (requirements analysis, design, development, testing, go‑live) to ensure delivery on time and within budget. Major projects that are either on going or in planning phase may include LIMS, WCS, Infrastructure build-up, facility expansion, Weighing and Dispense, Veeva, HR systems, Finance systems, Label Printing, MES, Automation and various satellite systems of SAP S/4 HANA. Ensure system compliance with regulatory requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, and data integrity (ALCOA+ principles) Lead the update of GMP‑related IT documents (SOPs, configuration manuals, training materials, etc.) to ensure compliance with the quality system requirements. Lead IT support for deviation investigations, change control, and CAPA (Corrective and Preventive Action) processes. Work business processes owners of the Nantong site, including but not limited to manufacturing operations, QA/QC, engineering, supply chain, warehouse, planning, procurement etc as well as support China Senior IT Director as co-owner of IT budget related to Nantong site, develop IT road map integrating with overall China and global OneIT strategy A good match: Bachelor's degree or higher in computer science, bioengineering, pharmaceutical engineering or a related field 10 years and above experience managing IT systems in the biopharmaceutical or pharmaceutical industry, with knowledge of GxP systems such as ERP, MES, LIMS or QMS. An expert with rich experience of CSV (Computerized System Validation), especially in GMP environment (e.g., LIMS, Empower, QMS). This includes defining validation strategies, and drafting/reviewing VMP (Validation Master Plan), URS (User Requirement Specification), FS (Functional Specification), Test Scripts, and other validation documentation. Hands-on experience implementing and supporting IT systems in regulated environments, including computer system validation and GAMP 5 guidelines Knowledge of data integrity principles, applicable regulations and GMP documentation, such as SOPs and validation protocols Experience leading IT projects and analyzing business processes; PMP or PRINCE2 certification is an advantage Strong cross-functional leadership and communication skills, with the ability to work in Chinese and English Your benefits: BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. How to apply: Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. 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. We are looking forward receiving 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 YouTu