about this position
Clinical Quality Assurance to serve as a key leader in Quality team.
Responsibilities
- Serve as the primary contact in QA for Clinical Studies activities to ensure compliance with all GCP’s from manufacturing, labeling, distribution and Clinical site activities to ensure compliance with US and EU Regulatory requirements.
- Provide support and response to quality compliance questions.
- Quality review of SOP’s, clinical study documents, Submission documents.
- Provide Quality oversight of vendors / CRO’s, including external audits.
- Liaise with Clinical and Regulatory functions for the Clinical studies
- Establish/ensure/remediate as needed the current Clinical Quality processes, systems and procedures associated with clinical studies
Duties
Requirements
- BSc. in a life science or similar scientific discipline (advanced degree preferred)
- A minimum of 2 years’ Clinical Quality Assurance experience in biotech/pharmaceutical companies (Phase 1-3 clinical trials), Auditing experience.
- Experience with QA oversight of multiple clinical studies being conducted in US and EU
- Ability to professionally interface with all levels (e.g. senior-level executives, staff, colleagues, external partners, consultants).
- Ability to initiate, prioritize and execute tasks with minimal direction.
- Strong leadership and communication skills
- Excellent verbal and writing skills in English
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