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Quality Lead
As a Quality Lead in the Pharma Development Quality division, you will develop and deliver robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner to ensure operations maintain high compliance standards while influencing the safe and efficient delivery of innovative therapies.
Responsibilities
- Drive risk-based Quality Assurance strategies using the Critical to Quality (CtQ) framework, focusing on GVP and GCP.
- Plan, perform, and lead global audits, identifying systematic trends to provide actionable quality data.
- Partner with business stakeholders to communicate audit observations and compliance risks.
- Support regulatory authority inspection preparation and management.
- Contribute to departmental goals and the continuous improvement of PDQ processes.
- Maintain expertise in global regulations including FDA, EU, and ICH guidance.
Requirements
- Bachelor’s degree in a scientific or quality-related field or equivalent experience.
- Proven experience in the pharmaceutical, biotech, or medical device industry.
- Strong understanding of global GxP regulations, specifically GCP, GVP, or IVD/MD frameworks.
- Excellent digital literacy with experience in audit management and analytical reporting tools.
- Strong problem-solving, decision-making, and project management skills.
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