Head of GDP Quality (m/f/d)
Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 1,600 employees in 36 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!
THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:- Ensure global risk-based quality systems in the supply chain, in particular in accordance with Good Distribution Practice, GMP and medical device requirements (CFR, MDr, DIN EN ISO 13485).
- Maintenance of a quality assurance system for distribution partners including Merz Affiliates as well as creation and update of the required SOPs.
- Implementation of quality improvement projects with regard to distribution partner management.
- Further development of the qualification system for global distribution partners with a focus on medicinal products and medical devices in cooperation with the units responsible for distribution partner management.
- Documentation of the formal qualification of the distribution partners with regard to the commissioned activities.
- Risk-based planning and implementation of audits of distribution partners
- Ensure continuous eligibility auditing of international customers and distribution partners and responsibility for listing and exclusion of DPs in SAP.
- Assessment of GDP and GMP relevant quality deviations and responsibility for usage decisions
- Responsible person GDP according to GDP guideline and §52a German Medicines Act
- Assure change control processes in cooperation with the responsible Merz production site and R&D in relation to sales activities.
- Degree in natural sciences (e.g. pharmacy, chemistry, biology) or comparable university degree.
- At least 7 years of professional experience in the manufacture and/or quality control of medical devices and medicinal products
- Experience in the qualification of suppliers and/or distribution partners and in the distribution of medical devices and medicinal products
- Profound knowledge of GDP and GMP
- Fluent in written and spoken English
- Proficient in MS Office applications and SAP IM, QM and SD
- Team-oriented, motivating and assertive personality
- Ability to work independently and to quickly learn new areas of responsibilities
-
Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our Employee Assistance Program.
-
Family and work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. We have been awarded the “Family-Friendly Company” certificate from the Hertie Foundation for our commitment to family and work.
-
Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flextime/trust-based working time and mobile working. Our employees also benefit from generous arrangements for annual leave.
-
Ongoing training: Your personal and professional development is the key to success for us. To this end, we hold regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.
Find out more about our benefits here.
We are looking forward to your application!
You can find more information at https://merz-aesthetics.info/
