QA Engineer focusing on quality assurance in a dynamic environment at BT Group. Collaborating with teams to enhance software reliability and product release confidence.
About the role
- Senior Manager overseeing GCP QA for clinical studies within Shionogi. Ensuring compliance with ICH GCP and FDA requirements while collaborating with various teams.
Responsibilities
- Provide quality oversight and GCP guidance to clinical study teams and vendors
- Ensure compliance with ICH GCP and FDA regulatory requirements
- Evaluate clinical trial documentation and processes
- Conduct regular vendor audits or assessments
Requirements
- BA/BS in life sciences or related field
- Minimum of 4 years of experience in a GCP QA/quality/compliance role
- Working knowledge of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements
- Experience in performing GCP-related audits
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work hours
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