Brand Manager Inflammation ((d) in Bad Homburg vor der Höhe bei Celltrion Healthcare Deutschland GmbH

Department:

QM/SCM

Location:

Office based (Bad-Homburg, Germany)

Reports To:

Head of QM/SCM

FTE

100% (40 hours/week)

We are Celltrion Healthcare.

Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines through an extensive global network that spans more than 120 different countries. Celltrion Healthcare provides REMSIMA, the world's first biosimilar monoclonal antibody (mAb) approved by the European Medicines Agency (EMA) for the treatment of autoimmune disease, and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. Celltrion Healthcare believes that every patient deserves access to the treatments they need. Based on this belief, Celltrion Healthcare has been steadfast in our mission to meet the needs of patients who previously had limited access to advanced therapeutics, since our inception in 1999.

Celltrion Healthcare Deutschland GmbH is a high-growth, fast-paced small organization. The ability to be productive and successful in an intense work environment is critical.

Position Summary:

The position of Quality Manager is newly created to ensure that our supply chain and logistics operations function in compliance with the EU GDP. Fulfillment of QM tasks, as well as definition, implementation, maintenance, and continuous development of QM processes in the pharmaceutical wholesale business

You will have the opportunity to shape and grow our brands, ensuring they effectively reach and resonate with the target audience, while working in a fast-evolving and growing organization.

What you can expect:

• Company Culture: Collaborative and inclusive work environment that values diversity and innovation. Regular team-building activities and social events to foster strong connections.
• Career Development: Ongoing training and professional development opportunities to enhance your skills and knowledge.
• Work-Life-Balance: Flexible work hours and remote work options to accommodate your personal commitments.
• Financial Security: Matching Company Pension Plan to help you to plan for the future

Duties and Responsibilities:

• Creation, Coordination, Documentation (archiving), Maintenance, and follow-up on the following:

1. Personnel Qualification Management – training and maintenance

2. Change Control Management

3. GDP relevant documentation (Quality manual and SOP, Formsheet management) - distribution, review, follow-up, format control, preparation, version control

4. Supplier and customer qualification as defined by internal SOP. Perform/coordinate audits. Maintain a qualified supplier list

5. Complaint Management: documentation, forwarding to GDP service provider, follow-up

6. Deviation Management: registration and internal follow-up

7. Recall – coordination and communication of recalls to authorities, customers, and other involved parties

8. Quality Agreement – creating, amendment, and managing.

9. Reporting – conduct regular management reviews

• Fulfil duties as a Wholesale Responsible person
• Contracting and business alignment: management and outsourced GDP service

Requirements:

A. Qualifications/Experiences:

• Bachelor's or Master's degree in Chemistry, Biochemistry, or a related field. A degree in Pharmacy is also desirable.
• At least 5-7 years of experience in quality assurance and quality control in the pharmaceutical industry. Experience in a supervisory or managerial role is desirable.
• Experience as a wholesale responsible person
• Good communication skills both in German and English

B. Personality:

• Must have the ability and strong desire to “Make things possible”.
• Must have a positive attitude.
• Must be willing and able to be “hands-on”.
• Must have a results-oriented work ethic.
• Agile mindset and flexibility, coupled with an independent way of working, strong communication skills and high team orientation