- Lead and maintain the site's GMP compliance program in alignment with regulatory requirements, corporate quality standards, and customer expectations.
- Ensure compliance with cGMP, Data Integrity and applicable regulatory guidelines.
- Monitor compliance trends and identify potential risks through periodic reviews and self-inspections.
- Drive continual improvement initiatives to strengthen the Quality Management System (QMS).
Regulatory Inspection Readiness
- Ensure continuous inspection readiness for USFDA, EDQM, MHRA, WHO, PMDA, TGA, and other regulatory inspections.
- Coordinate preparation activities for regulatory and customer audits.
- Lead audit management activities, including response preparation, CAPA tracking, and effectiveness verification.
- Conduct mock audits and gap assessments to evaluate site preparedness.
Quality Management System Oversight (Optional)
- Ensure timely closure and effectiveness of:
- Deviations
- OOS/OOT investigations
- CAPA
- Change Controls
- Market Complaints
- Supplier Quality Issues
- Risk Assessments
- Review compliance metrics and escalate critical issues to site leadership.
Data Integrity Governance
- Lead implementation and monitoring of Data Integrity programs across QC, QA, Manufacturing, Engineering, Warehouse, and computerized systems.
- Conduct periodic Data Integrity assessments and audits.
- Ensure compliance with ALCOA+ principles and computerized system controls
Internal Audit & Self-Inspection Program
- Establish and manage annual self-inspection schedules.
- Review audit observations, root cause investigations, and CAPA implementation.
- Monitor effectiveness of corrective and preventive actions.
Regulatory Intelligence and Compliance Monitoring
- Track changes in global regulatory requirements and industry trends.
- Assess impact and ensure timely implementation of recent regulatory expectations.
Training and Quality Culture
- Promote a proactive quality and compliance culture across the organization.
- Develop annual GMP and Data Integrity training plans.
- Conduct awareness programs on regulatory expectations and inspection preparedness.
- Mentor teams on quality risk management and investigation excellence
Compliance Metrics and Management Review
- Develop and monitor site compliance KPIs, including:
- Audit observations
- CAPA closure timeliness
- Deviation closure performance
- Change control compliance
- Training compliance
- Data Integrity observations
- Customer complaints
- Present compliance trends and risk assessments during Management Review Meetings.