We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations....+ ←

Bad Homburg / Hessen · Permanent · Full-time · As of now

Manager Quality Management & GxP Compliance (m/f/d)

Your assignments

• Monitoring and securing GxP compliance according to internal policies and regulatory standards.
• Managing activities to maintain quality management system compliance, including document, change, and deviation management.
• Preparing, updating, and reviewing quality management documents such as SOPs, work instructions, guidance, and validation documents.
• Planning and conducting trainings on quality techniques and regulations (e.g. CSV, EU GMP).
• Having responsibility as Quality Manager for GxP-relevant computerized systems
• Validation of QM/RA processes in GxP-relevant computerized systems across the entire system life cycle (e.g. development of strategies, preparation of plans/reports).
• Coordinating periodic reviews of systems and processes.
• Participating as a GxP compliance expert in supplier audits and collaborating with Fresenius Kabi internal IT on GxP activities.

Your profile

• Completed studies in natural science (such as biochemistry, biology, pharmacy, mathematics) or engineering (such as biotechnology, medical technology)
• Minimum of three years of experience in a GxP regulated environment, especially in quality management
• Advanced expertise in validating GxP-relevant computerized systems
• Good knowledge of GAMP 5 and relevant regulations (e.g. 21 CFR Part 11 and EU GMP Annex 11)
• Familiarity with electronic systems used in Quality Management (QM) and Regulatory Affairs (RA)
• Experience with both traditional and agile project management methodologies as well as first experiences with AI in the GxP environment
• Excellent English language skills (spoken and written), along with experience working in virtual and multicultural teams
• Team-oriented with high quality awareness, confident communication, intercultural competence, solution-oriented and structured thinking, independence, organizational strength, and advanced software skills (MS Office, Visio, SharePoint, Trackwise, Documentum)

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Your contact

Konstantin Kasatschkov
Fresenius Kabi Deutschland GmbH
Bad Homburg
Ref.-Number: R-10013037

Job category:

Quality Management

Working condition:

Full-time

Business segment:

Fresenius Kabi

Location:

Bad Homburg / Hessen

Closing date for application:

none – We are looking forward to your application

More information

Information about the application process

Our offer at a glance

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
fresenius-kabi.com

We seek talents and perspectives

At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.

All terms used in this job advertisement to denote persons refer to all genders equally.

#careerswithapurpose at Fresenius

Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.