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.