Act as a trusted QA partner to Clinical and Medical Affairs stakeholders by providing proactive quality advice, risk assessment and oversight.
Instill a consistent mindset and culture through partnering with stakeholders to streamline the product lifecycle process by embedding proactive quality approach.
Quality by Design (QbD) and supporting risk-based decision making, developing risk mitigation strategies across projects and initiatives.
Lead and support inspection readiness and management activities, including acting as Inspection Management Team Lead and coordinating pre- and post-inspection activities.
Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidences are not resolved in due course.
Provide guidance during the root cause analysis and development and execution of Corrective and Preventive Actions (CAPAs).