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Director of Quality Assurance
vor 2 Wochen
Our client, a leader in medical device and pharmaceutical manufacturing, is seeking a Director of Quality Assurance for their Frankfurt location. This is a newly created position and will oversee GCP and R&D.
**Responsibilities**:
- Ensure compliance for R&D and all Global clinical studies
- 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 performance management, training, and task oversight
- Identify and escalate compliance risks or issues
- Utilize Global R&D Quality Management System in support of daily operations and audit management
- Manage global audits and inspections
- 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
- 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
- Facilitate and support projects to improve R&D compliance and operational efficiencies
- Ensure applicability of current quality policies, procedures, and objectives by staying 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
Qualifications:
- Bachelor's degree required
- Master’s degree preferred
- 15+ years experience in Clinical Quality/Compliance
- 7+ years Audit experience
- 5+ years experience in Medical Device Clinical Trials or Biologic Clinical Trials
- 5+ years staff management experience
- Strong knowledge of US and EU/International GxP (GCP, GLP, GDP) and medical device regulations and guidance
- Strong verbal and written communication skills
Pay: 100.000,00€ - 115.000,00€ per year
Ability to Relocate:
- Frankfurt: Relocate before starting work (required)
Work Location: In person
