Senior Manager Clinical Quality Assurance (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:- Oversight of the global clinical quality program this includes conducting site, supplier, documentation, eTMF and other audits in support of global research and development of medical devices, pharmaceuticals and biological products.
- Ensure all global clinical studies are compliant with current regulatory requirements.
- Develop study-specific Quality Audit Plans to support audit conduct through study lifecycle and support clinical study teams throughout the course of the trial.
- Attend clinical study meetings to provide consistent Quality oversight.
- Manage staff, including performance management, training, and task oversight.
- Identify and escalate compliance risks or issues and ensure R&D compliance with procedural and regulatory requirements.
- Manage global audits and inspections, including the management of corrective and preventive actions to successful resolution.
- Independently and objectively conduct audits within multiple GCP areas, including Investigator site, vendor, documentation, eTMF for both drug and device clinical trials.
- Collaborate with Clinical Operations and Ax R&D Quality colleagues to consistently disseminate audit findings.
- Perform peer reviews of audit reports from Ax R&D Quality colleagues.
- Support development of the annual R&D Global GxP Quality Audit plan, including resourcing and managing external independent auditors as needed.
- Support Issue Management activities, which includes NCR, CAPA Management, & Change Requests by R&D functions.
- Ensure compliance with procedural document management activities as defined by the Merz Quality Management system, department, project team, and corporate objectives.
- Provide support as needed for potential procedural updates.
- Identify and implement process changes within the R&D processes to support continual process improvement.
- Facilitate and support harmonization initiatives within the R&D group and projects to improve R&D compliance and operational efficiencies.
- Keep informed of the latest updates/changes related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.)) and ensure applicability of current quality policies, procedures and objectives.
- Provide updates to R&D team members, communicate effectively across functions, and escalate questions/issues to management as appropriate.
- Assist other R&D staff as needed and perform tasks and assignments as required.
- Perform additional duties as needed to support the business and overall company objectives.
- Bachelor's or Master's degree in a relevant scientific or technical field.
- Minimum of 10 years relevant Clinical Quality/Compliance experience
- Minimum of 7 years previous Audit experience
- Minimum of 5 years relevant experience in Medical Device Clinical Trials and Biologic Clinical Trials
- Excellent knowledge of US and EU/International GxP (GCP, GLP, GMP, GDP) and medical device regulations.
- Strong leadership, management, and interpersonal skills.
- Excellent communication and problem-solving skills.
- Ability to work independently, prioritize workload, and manage multiple tasks simultaneously.
- Ability to travel domestically and internationally up to 30% of the time.
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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.
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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.
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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.
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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/
