Senior Clinical Quality Manager
il y a 2 semaines
Skills Alliance is seeking a Quality Assurance Manager to strengthen its clinical team.
Main Activities and Responsibilities:
- Develop and track the clinical quality system to ensure effective documentation and implementation.
- Implement and monitor risk management plans for clinical trials, ensuring compliance with established audit schedules.
- Evaluate non-conformities, deviations, and complaints, and manage the implementation of preventive or corrective action plans.
- Organize and oversee internal and external quality audits, including those conducted by third-party service providers.
- Conduct quality control of clinical documentation and self-inspections, maintaining up-to-date knowledge of FDA, EU, and national regulations.
- Lead improvements in quality systems and processes to support evolving regulations and company development initiatives.
- Raise awareness among teams by organizing GxP-compliant quality training programs.
- Perform other GCP-related tasks and collaborate with R&D and QA/RA departments as needed.
Requirements:
- Bachelor's degree in a relevant field.
- 3+ years of experience within Medical Device, Pharma, Biotechnology.
- Extensive experience within clinical trials and quality assurance, with in-depth knowledge of GCP Quality Management Systems.
- Fluent in verbal and written English.
Company Offers:
- Hybrid flexibility.
- The chance to contribute to the development of disruptive technology within a fast-growing company, working with a dynamic and supportive team.
- Competitive salary and benefits.
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