SAP Compliance Manager m/f/d

Ensure Compliance. Drive Quality. Enable Digital Transformation.

Are you passionate about compliance, validation, and quality in complex SAP environments?

Join CordenPharma and play a key role in ensuring our global SAP S/4HANA landscape remains compliant, validated, and audit-ready.

Working closely with IT, Quality Assurance, Business Process Owners, and external auditors, you will help shape the future of our digital landscape in a highly regulated pharmaceutical environment.

• Ensure compliance of SAP S/4HANA and connected applications with GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity requirements
• Manage SAP-related deviations, CAPAs, and changes
• Coordinate and support Computer System Validation (CSV) activities throughout the system lifecycle
• Prepare and support internal audits, customer audits, and health authority inspections
• Ensure compliance within SAP change and release management processes
• Drive continuous improvement of compliance processes, controls, and governance
• Act as a trusted partner between IT, QA, and the Business

Perfil

• Degree in Computer Science, Business Informatics, Life Sciences, Pharmacy, or a related field
• Several years of experience in a regulated environment such as Pharma, Biotech, MedTech, or Chemicals
• Strong knowledge of:
• SAP ERP / SAP S/4HANA
• Computer System Validation (CSV)
• GAMP 5
• FDA 21 CFR Part 11
• EU GMP Annex 11
• Data Integrity
• Experience with audit readiness, CAPA, deviation, and change management
• Strong stakeholder management and communication skills
• Fluent English

Oferecemos

• Employee Events
• Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative
• Hybrid working opportunities