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Clinical Quality Assurance Expert
3 weeks ago
Job Description
- As a Clinical Quality Assurance Program Lead, you will provide quality oversight for the end-to-end clinical process for assigned programs/trials to ensure compliance with health authorities' requirements and internal standards.
- You will drive the implementation of quality strategies within global clinical teams, monitor the implementation of annual quality plans, and ensure adequate oversight of proactive quality risk management processes.
- In addition, you will provide robust and clear quality oversight in areas of clinical development, including supporting key stakeholders, collaborating on governance for quality incident management, and providing guidance on Good Clinical Practice (GCP).
Key Responsibilities:
- Proactively provide QA leadership to business strategy for assigned programs/trials by ensuring considerable organization awareness.
- Drive implementation of quality strategy within global clinical teams under responsibility.
- Regularly monitor the implementation of the annual Quality Plan pertaining to assigned programs/studies.
- Ensure adequate oversight of proactive quality risk management process in overseen areas including quality risk assessments and submission/inspection readiness activities.
- Provide Good Clinical Practice (GCP) guidance to day-to-day questions arising from clinical trials deliverables.
Required Skills and Qualifications
- Bachelor's degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred.
- 7 years of involvement in regulated activities (GCP/Pharmacovigilance (PV)), clinical development and/or QA positions.
- Broad understanding of global expectations of health authorities in the area of Clinical Development and profound understanding of the science of product development.
- Ability to work independently and in a global/matrix environment.
- 3 or more years' experience in managing projects.
- Strong skills in GCP, quality and/or clinical development.
Benefits
Collaborating, supporting, and inspiring each other as a community of smart and passionate people like you. Combining to achieve breakthroughs that change patients' lives.
Seniorities
Director
Employment Type
Full-time
Job Function
Health Care Provider
Industries
Pharmaceutical Manufacturing
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