Our client is a global leader in life sciences and biopharmaceuticals, offering unparalleled opportunities to impact healthcare. The Quality Director will play a crucial role in leading and inspiring quality teams, ensuring the highest standards of quality, directly impacting the safety and efficacy of life-saving treatments for patients worldwide.
Roles and Responsibilities:
- Lead and Inspire Teams: Cultivate high-performing teams that excel in meeting business demands while upholding quality and regulatory standards.
- Global Collaboration: Engage with international teams and key stakeholders to harmonize quality strategies across the globe.
- Resource Management: Strategically manage resources and financial planning to meet both business and quality objectives.
- Audit Readiness: Guarantee the site is always prepared for client audits, internal audits, and regulatory inspections.
- Investigate Issues: Lead thorough investigations into events, complaints, and data audits to ensure resolution.
- Ensure Compliance: Uphold rigorous regulatory standards in all operations and reporting.
- Risk Mitigation: Proactively identify and address key risks through effective collaboration.
- Document Review: Approve and oversee critical GxP documents and quality records with precision.
- KPI Reporting: Deliver insightful performance metrics to senior management.
Qualifications
- B.Sc. in Life Sciences, MSc or PhD preferred.
- 10+ years of management experience in quality.
- 10+ years in a GMP and GLP environment in a regulated industry (pharmaceutical, biopharmaceutical preferred).
- Strong global mindset, flexibility to work across time zones, relationship-building, negotiation, and change management skills.
