SAP Compliance Manager m/f/d

Corden Pharma - A Full-Service CDMO; Lisboa; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Employee Events

Positive work culture

Hybrid work

Resumo da oferta

CordenPharma is seeking a compliance and SAP specialist to maintain and validate our SAP S/4HANA landscape in a highly regulated pharma environment. You will collaborate with IT, QA, and process owners to ensure audit readiness and data integrity across systems.

Key tasks include managing deviations, CAPAs, changes, and CSV activities, supporting internal and external audits, and driving governance improvements within change management processes. Fluent English required.

Qualificações

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

Responsabilidades

• Ensure compliance of SAP S/4HANA and connected applications with GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity.
• 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.

Conhecimentos

Regulated environment experience

Stakeholder management

Communication skills

Fluent English

Formação académica

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

Ferramentas

SAP ERP / SAP S/4HANA

CSV

GAMP 5

FDA 21 CFR Part 11

EU GMP Annex 11

Data Integrity

Descrição da oferta de emprego

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.