Job Description

• 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).
• Collaborat...