GCP Compliance Specialist
3 giorni fa
We're hiring a seasoned Clinical Quality Assurance Manager to spearhead the implementation of GCP-compliant systems and processes at Philogen S.p.A.
As a critical member of our quality team, you'll drive the development of clinical SOPs, manage training initiatives, evaluate vendor relationships, and conduct quality reviews and audits.
- Leverage your knowledge of GCP/ICH to create efficient systems and processes.
- Foster collaboration among cross-functional teams to establish quality standards.
- Develop and deliver comprehensive employee training programs.
- Validate the qualifications of service providers and collaborators.
- Verify the completeness and consistency of clinical trial documents.
- Anticipate and address potential compliance risks.
- Plan, execute, and follow up on site audits.
- Deliver expert guidance to audited sites and companies.
The ideal candidate will bring:
- A solid scientific foundation or extensive experience in quality assurance.
- Minimum 3-5 years of experience in clinical quality management.
- Deep understanding of GCP principles, EU regulations, and ICH guidelines.
- Exceptional written and spoken English skills.
- Outstanding analytical and organizational abilities.
- Capacity to handle multiple priorities, delegate tasks, and build high-performing teams.
- Results-driven mindset and creative problem-solving skills.
We encourage candidates with varied backgrounds to apply.
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