中国，上海; 南通，中国 | 全职 | Job ID: 10361
About the role:
About the Role: The IT system validation manager is responsible for the validation of the IT systems (largely SAP S4HANA), which shall operate in compliance with the company QMS and relevant regulatory frameworks, including pharma GxP guidance, US FDA 21 CFR Part 11, EU GMP Annex 11, and US Sarbanes-Oxley (SOX) Section 404. The position acts as Computer System Validation (CSV) project lead and thus plays a critical role in maintaining the validated state of ERP and other IT applications supporting the manufacturing site of Nantong. It extends to all other relevant compliance activities, such as compliance framework development/update, Deviation- and CAPA management, change control and periodic review support:
Your contribution:
Act as CSV project lead responsible for the validation strategies and management of the computer systems in scope
Preparation and review of CSV documents in accordance with standard operating procedures, laws and guidelines
Contribute to change management, deviation resolution and CAPAs, in close coordination with IT, QA, and business stakeholders
Act as an SAP ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections
Relevant higher education and 8+ years of professional experience
Proven track record of CSV and other compliance expertise within GxP regulated industries, ideally pharma, with experience in US, EU and China GxP regulations
Well-organized with excellent documentation and analytical skills; able to synthesize complex information into clear, actionable insights
Ability to familiarize yourself with a variety of different technical or regulatory topics, with attention to detail and a quality-first mindset
Strong communication and stakeholder management skills, with the ability to interact confidently with business stakeholders, auditors, and cross-functional teams
Fluency in English and Mandarin required
BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。
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