Director of Quality Assurance and Compliance
3 days ago
EPM Scientific - Phaidon International seeks a Director of Quality Assurance and Compliance to drive quality excellence in the region. This leadership role will be responsible for leading high-performing teams and ensuring quality and regulatory standards are met.
Main Responsibilities
- Quality Leadership: Lead and motivate high-performing quality teams to meet business needs.
- Global Collaboration: Collaborate with international teams and stakeholders to align quality strategies across regions.
- Resource Allocation: Efficiently manage resources and financial plans to achieve business and quality goals.
- Audit Preparation: Ensure the region is always prepared for audits, investigations, and inspections.
- Incident Investigations: Conduct thorough investigations into incidents, complaints, and data discrepancies.
- Regulatory Adherence: Maintain strict adherence to regulatory standards in all operations and reporting.
- Risk Mitigation: Identify and mitigate key risks through effective collaboration.
- Document Approval: Review and approve essential documents and quality records accurately.
- Performance Insights: Provide senior management with insightful performance metrics.
Qualifications
- Education: Bachelor's degree in Life Sciences; MSc or PhD preferred.
- Experience: Over 10 years of experience in managing quality teams.
- Industry Experience: More than 10 years in a regulated industry environment within a GMP setting (preferably pharmaceutical or biopharmaceutical).
- Global Skills: Strong global mindset, ability to work across time zones, and skills in relationship-building, negotiation, and change management.
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