You oversee ERP compliance and manage deviations, collaborating closely with various teams to ensure adherence to quality standards and regulations. This role involves documentation, working together on validations, and serving as a subject matter expert during audits.
Anforderungen
- •Relevant higher education
- •More than 5 years of experience
- •Proven track record in compliance
- •Experience with GxP regulations
- •Expertise in deviation/CAPA and SOX
- •Understanding of SAP or ERP applications preferred
- •Well-organized with excellent documentation skills
- •Strong analytical skills
- •Ability to synthesize complex information
- •Attention to detail and quality-first mindset
- •Strong communication skills
- •Stakeholder management skills
- •Ability to interact confidently
- •Fluency in English
- •Knowledge of German preferred
Deine Aufgaben
- •Ensure ERP compliance with GxP, SOX, and GDPR.
- •Manage ERP deviations and non-conformances effectively.
- •Implement Corrective and Preventive Actions with stakeholders.
- •Document and track deviation/CAPA status and trends.
- •Collaborate with SOX team to monitor ITGCs and controls.
- •Support computer system validation efforts with relevant teams.
- •Manage change activities for ERP systems and assessments.
- •Act as ERP compliance SME during audits and inspections.
Deine Vorteile
Flexible hours and vacation
Digital learning opportunities
Performance and talent development
Leadership development programs
Apprenticeships available
LinkedIn Learning access
Voice at the table
Equal footing culture
Opportunities to shape impact
Support for full potential
Company bike availability
Job ticket for mobility
Deutschlandticket availability
Employer-funded pension plan
Childcare support
Original Beschreibung
# (Senior) Engineer ERP Compliance - SOX/CAPA
Mainz, Germany | full time | Job ID: 9065
The (Senior) Engineer ERP Compliance is responsible to ensure that all ERP systems in scope operate in compliance with relevant regulatory frameworks, including GxP (Good Practice), FDA 21 CFR Part 11, EU GMP Annex 11, and Sarbanes-Oxley (SOX) Section 404. The position plays a critical role in maintaining the validated state of ERP applications focusing on deviation and CAPA management and contribution to established SOX controls. It extends to all compliance activities, such as validation, change control and periodic review. Your responsibilities are:
• Ensure continuous compliance of ERP applications with GxP, SOX and GDPR requirements
• Manage ERP-related deviations and non-conformances, ensuring investigation, impact assessment, root cause analysis, and timely resolution in line with quality system expectations
• Drive effective and sustainable Corrective and Preventive Actions (CAPAs), in close coordination with IT, QA, and business stakeholders to implement remediation and preventive measures
• Maintain documentation and tracking of deviation/CAPA status and provide trend analysis and periodic reporting to compliance leadership
• Collaborate with the SOX team and SOX control owners to monitor and test SOX ITGCs and application-level controls, ensuring compliance with financial reporting obligations. Contribute to SOX control improvements
• Support computer system validation (CSV) efforts for project and run-and-maintain, in collaboration with the CSV team, functional experts and QA
• Support change management activities for ERP systems, ensuring that all changes are subject to impact assessment and implemented according to validated system procedures
• Act as an ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections.
What you have to offer.
• Relevant higher education and 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
• Well-organized with excellent documentation and analytical skills; as well as the ability 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, German knowledge is preferred
**Your Benefits:**
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Job ID 9065 (please always specify if you have any questions)
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.
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