Jobbeschreibung
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 2,500 employees in 26 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!
Senior / Lead Quality Assurance Manager (m/f/d)
- You plan and perform various Clinical medical devices & medicinal products project audits against GxP and local regulatory requirements.
- You create audit plans for the studies, based on risk assessments/analyses, as well as plan and perform internal process and vendor audits.
- You lead the evaluation and management of clinical site-specific escalations related to persistent or serious misconduct.
- You collaborate in the further development and maintenance of the Quality Management System, e.g., document management, CAPA, deviation, and SOP System.
- You assist in the development of Company Standard Operating Procedures and collaborate on quality metrics for reporting to leadership.
- You act as a QA Business Partner for the Clinical Operation team to overview and support relevant ClinOps sub-divisions on CAPAs management.
- You provide independent consultation with a focus on clinical activities and for quality-related and GCP-related inquiries for Clinical activities in Ax R&D.
- You support the qualification process of suppliers relevant for clinical development.
- You plan and perform various clinical vendors audits against GxP and local regulatory requirements.
- You contribute to training for selected functional groups related to Good Clinical Practice, Good Clinical Laboratory Practice, Good Pharmacovigilance Practice (pre-marketing related), and clinical trials regulations.
- You host the local and international Notified Body and authorities' inspection/External Audits.
- You manage CAPA of the RA inspections/External Audits as well as support inspection readiness/regulatory compliance status at R&D.
- You ideally hold a Master's Degree in natural science, pharmacy, or medicine.
- You have 10 years of professional experience in the field of clinical research oversight and/or management.
- You have 5 years of professional experience as a QA Auditor and executing a QA Manager role in the pharmaceutical/medical device industry.
- You ideally have prior experience developing risk-based quality management programs across clinical development.
- You have first experience working and communicating within cross-functional and international teams.
- You understand the overall clinical trial management process, including the protocol and other clinical trial-related plans and documents.
- You have critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data.
- You have comprehensive knowledge of the regulations and standards for conducting clinical trials in the field of medical devices or medicinal products.
- You possess comprehensive knowledge in the execution of audits in the "GCP" area (medical device products: ISO 14155 or pharmaceutical: ICH-GCP "E6").
- You manage and facilitate audits/inspections.
- You understand the ICH and regulatory environment.
- You are an analytical thinker with strong communication skills and the ability to work independently.
- You are highly motivated and willing to learn new areas of work, as well as like to travel nationally and internationally for audits (average 20% of travel).
- You demonstrate a high level of commitment, discretion, sense of responsibility, reliability, accuracy, and confident appearance.
- You are business fluent in English, additional languages skills in German are preferable.
- You possess strong Microsoft Office skills.
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 different internal and external support systems.
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. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.
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 flex-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 foster this, we conduct 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.
Mehr