Senior Compliance Manager ERP Applications

BioNTech SE; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

An innovative biotech company in Mainz is seeking a Senior Compliance Manager ERP Applications. This role involves ensuring ERP systems comply with regulatory frameworks, acting as CSV project lead, and managing compliance activities. The ideal candidate has over 5 years of experience in compliance within regulated industries, with strong communication and analytical skills. This position offers flexible hours and numerous growth opportunities.

Leistungen

Flexible hours

Digital learning opportunities

Company bike

Employer-funded pension

Qualifikationen

• More than 5 years of professional experience in compliance.
• Proven track record in regulated industries.
• Extensive experience in GxP regulations.

Aufgaben

• Ensure compliance of ERP applications with regulations.
• Act as CSV project lead for validation strategies.
• Preparation and review of compliance documents.
• Continuous improvement of the compliance framework.

Kenntnisse

Fluency in English

Communication skills

Analytical skills

Attention to detail

Stakeholder management

Ausbildung

Relevant higher education

Jobbeschreibung

Mainz, Germany | full time | Job ID: 9322

The Senior Compliance Manager ERP Applications is responsible for ensuring 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 acts as CSV project lead and thus plays a critical role in maintaining the validated state of ERP applications. 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 responsibilities are:

• Ensure continuous compliance of ERP applications with GxP, SOX and GDPR requirements.
• 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.
• Continuous improvement of the compliance framework.
• Contribute to change management, deviation resolution and CAPAs, in close coordination with IT, QA, and business stakeholders.
• 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 (more than 5 years)
• Proven track record of CSV and other compliance topics within regulated industries (e.g., pharma, chemical, medtech).
• Extensive experience in 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. 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

Apply now - We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9322 (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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BioNTech, the story

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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