SAP Compliance Manager m/f/d

Introduction

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DP), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the US, provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision: We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

What you can expect

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

To successfully master this role, we are looking for the following qualifications:

• 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

What we offer

Employee Events

Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative

Hybrid working opportunities

Interested?

If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own area of responsibility, then you should join our team.

CordenPharma does not accept unsolicited applications from recruitment agencies. Any resumes submitted without a prior agreement will not be considered and will not create any obligations for CordenPharma.