Senior Compliance Manager ERP Applications | Data Analyst (m/w/d)
BioNTech SE
Job Summary
This role is for a Senior Compliance Manager specializing in ERP applications, ensuring all systems adhere to critical regulatory frameworks like GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and Sarbanes-Oxley (SOX) Section 404. The successful candidate will manage ERP-related deviations and CAPAs, conduct root cause analyses, and drive effective remediation. They will also support computer system validation (CSV) and change management activities, act as a subject matter expert during audits, and collaborate with SOX teams to monitor ITGCs. This position is ideal for a professional with a strong background in regulated industries, offering the chance to maintain the validated state of critical ERP applications and contribute to robust compliance frameworks in a dynamic environment.
Required Skills
Education
Relevant higher education
Experience
- Many years of professional experience (> 5 years)
- Proven track record of compliance topics within regulated industries (e.g., pharma, chemical, MedTech)
- Experience with GxP regulations
- Expertise in deviation/CAPA and SOX is a plus
- Understanding of SAP or ERP-related applications preferred
Languages
Additional
- Not specified
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