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It/ot Quality and Compliance Business Consultant
hace 1 semana
Tasks and responsibilities:
- He/she will be responsible for defining, implementing, and monitoring the IT & OT compliance concepts and to drive IT INF products and services with legal, regulatory requirements as well as with corporate compliance policies where applicable.
- By establishing IT INF audit preparation support and effective IT & OT guidance, She/he ensures that the processes in the global organization are according to our regulations and best practices.
- She/he is responsible for the continuous improvement of compliance topics and revision of corporate IT & OT instructions, as well as identifies Quality and Compliance Uses Cases to automate and thus, simplify the life of the System Leads within IT INF, and to improve monitoring and control of IT INF compliant status
Technical implementation of the automation is out of his/her scope)
- She/he independently analyzes new trends and strategic goals in the field of audit and compliance and regulations (e.g. benchmarks with other pharmaceutical companies) and special requirements of new technologies/trends (e.g. agile methods, data integrity, cloud) in order to adapt our high quality standard to the rapidly changing framework conditions.
Requirements:
- Bachelor's degree in Computer Science or comparable experience or similar
- At least 5 years of experience with quality management systems and processes (e.g. GAMP, deviations and CAPAs, IT4OT) and IT standards.
- Indepth knowledge of the regulatory environment (e.g. GxP, Data Integrity, audits) and information technology
- Solid understanding of manufacturing/production processes
- Foundational knowledge of GxPrelevant IT processes and their support by computerized systems (e.g. GoTrack, ServiceNow, ITEMS, Veeva Vault)
- Experience working in an international and intercultural environment and availability to travel.
- Broad knowledge in the areas of Quality and Compliance, process governance, risk management
- Experience on audits (internal or externals)
- Certification in auding / compliance frameworks are a plus (ISA/IEC 62443, CISA, ISO
- Professional experience managing Operational Technologies is a plus.
- Excellent spoken and written English.
#IamBoehringerIngelheim because:
With us, you can grow, collaborate, innovate, and improve lives. We offer challenges in a global, respectful, and family-like work environment where ideas drive our innovative mindset. Flexible learning and continuous development for our team are key because your growth is our growth.
We are continuously working to design the best experience for you.
Here are some examples of how we will take care of you:
- Flexible working conditions
- Life and accident insurance
- Health insurance at a competitive price
- Investment in your learning and development
- Gym membership discounts
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