SAP Compliance Manager m/f/d

Corden Pharma GmbH; Lisboa; Híbrido; EUR 70 000 - 100 000; Tempo integral

Resumo da oferta

CordenPharma in Lisbon seeks an SAP Compliance Manager to ensure the SAP S/4HANA landscape remains compliant, validated, and audit-ready within a highly regulated pharmaceutical environment.

You will collaborate with IT, QA, and Process Owners to uphold data integrity, manage deviations, CAPAs, and changes, and drive continuous improvement in compliance governance.

Qualificações

• Degree in a relevant field and experience in regulated environments.
• Several years of experience in Pharma, Biotech, MedTech, or Chemicals.
• Strong knowledge of SAP S/4HANA, CSV, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, Data Integrity.

Responsabilidades

• Ensure SAP S/4HANA and connected applications comply with GxP, Part 11, Annex 11, and Data Integrity requirements.
• Manage SAP-related deviations, CAPAs, and changes.
• Coordinate and support CSV activities across 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.

Conhecimentos

GxP Compliance

Stakeholder Management

Audit Readiness

CAPA & Deviation

Change Management

Regulatory Knowledge

Communication Skills

Formação académica

Degree in Computer Science, Business Informatics, Life Sciences, Pharmacy, or related field

Ferramentas

SAP S/4HANA

SAP ERP

Descrição da oferta de emprego

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 3,500 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe, Asia 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.

SAP Compliance Manager m/f/d

• Lisbon
• as soon as possible
• Full-time
• Permanent

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

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.