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Director Quality Assurance (d/f/m)

Full Time
Frankfurt am Main, Deutschland
Experienced Professional
January 11, 2024
Hybrid
Director Quality Assurance (d/f/m)

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:
  • Assure all Global clinical studies are compliant with current regulatory requirements
  • Support clinical study teams throughout course of trial by developing study- specific Quality Audit Plans to support audit conduct through study lifecycle  
  • Attend clinical study meetings to provide consistent Quality oversight
  • Responsible for the management of staff including performance management, training and task oversight
  • Ensure consistent and robust management of subordinate task completion per procedural expectations and departmental objectives
  • Effectively identify and escalate compliance risks or issues
  • Successfully utilize Global R&D Quality Management System in support of daily operations and audit management
  • Ensure R&D compliance with procedural and regulatory requirements
  • Responsible for managing 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 but not limited to: Investigator site, vendor, documentation, eTMF for both drug and device clinical trials
  • Perform audit management tasks in accordance with expected procedural timeframes
  • Ensure compliance with procedural document management activities as defined by Merz Quality Management system, department, project team and corporate objectives
  • Provide support as needed for potential procedural updates
  • Responsible for identifying and implementing process changes within the R&D processes to support continual process improvement
  • Facilitate and support harmonization initiatives within the R&D group
  • Facilitate and support projects to improve R&D compliance and operational effiiciencies
  • Ensure applicability of current quality policies, procedures and objetives by keeping informed of the latest updates/ modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.)
  • Provide updates to R&D staff as applicable 
WHAT WE EXPECT FROM YOU:
  • Bachelor's or Master's degree in a relevant scientific or technical field
  • At least 15 years relevant experience in Clinical Quality/ Compliance
  • Min. 7 years experience in previous Audits
  • Min. 5 years relevant experience in Medical Device Clinical Trials, Biologic Clinical Trials, staff management
  • Proficient in all MS Office applications 
  • Strong knowledge of US and EU/ International GxP (GCP, GLP, GDP) and medical device regulations and guidance
  • Ability to work effectively in a global matrix environment
  • Strong verbal and written communication skills
WHAT YOU CAN EXPECT FROM US:
  • 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/

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