Compliance

• Conduct data analytics/review to enable proactive detection of quality and compliance signals and trends.
• Drive remediation plans based on the signals and trends.
• Lead successful and timely execution of quality and compliance improvement initiatives.
• Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness.
• Provide technical SME support and BOH response writing/review.
• Work in coordination with the QO Leads and QPL to drive the site regulatory strategy for key products, site digital strategy and continuous improvement initiatives.
• Provide technical inputs to evaluate investigations, product and process issues, including the ability to identify root cause and corrective and preventative actions, and accountable to provide leadership to drive issues to timely resolution.
• Provide rapid and effective cross-site coordination of significant investigation activities associated with low bioburden/sterile products.
• Prepare and facilitate Quality/OpU Quality Review meetings.

Operations Compliance Lead

Senior Export Compliance Officer

Senior Manager, Compliance Monitoring and Oversight

Regulatory Engineer

Executive Director, Regulatory Science & Strategy – Oncology

Fund Compliance Manager