Pharmacist (m/w/d)

BioNTech SE

55131 Mainz am Rhein - Deutschland

Pharmazeut/in Arbeit Vollzeit ab 10.09.2025

Beschreibung

Senior Compliance Manager ERP Applications
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.
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.

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.
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

Quelle: Bundesagentur für Arbeit - Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.