Quality and GCP Oversight

• Provide quality consultation within assigned scope, escalating complex or enterprise- impacting issues to the Senior Global Quality Manager and/or Global Head - GCP Excellence, as appropriate

• Lead issue assessments, root cause evaluation, and recommendations for QA escalation

• Lead cross-study quality initiatives to define best practices, enhance quality maturity, and strengthen proactive risk identification

• Support teams in interpreting and applying ICH GCP, regulatory expectations, procedural documents, and governance frameworks

• Provide direction for deviat...