Quality Assurance Manager
3 days ago
Daiichi Sankyo, Inc. is a pharmaceutical company dedicated to creating innovative therapies for improved healthcare outcomes. With over 125 years of experience and operations in 20 countries, our organization prioritizes quality and compliance.
Job Summary
We are seeking a Quality Assurance Manager who will support our Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner Quality Leads in ensuring perpetual compliance. The ideal candidate will have expertise in GxP/GCP regulations, global project management, and collaboration with cross-functional teams.
Key Responsibilities
- Quality Oversight: Review and monitor Quality Events (QEs), CAPAs, and GCP compliance matters raised to the Global Quality Lead(s) and Regional Quality Leads from internal and external study teams.
- CAPAs and Lessons Learned: Support the development and implementation of Corrective and Preventive Actions (CAPAs) related to GCP audits and participate in formal investigations of quality events.
- Risk-based Quality Oversight: Contribute to the measurement of DS KPIs/KQIs and provide interpretation of GCP regulations and company process standards.
Requirements
- Bachelor's Degree in a scientific discipline, healthcare, or related field.
- Minimum 4 years of professional industry experience within Quality (GxP/GCP).
- Experience supporting global projects in both the US and Europe.
- Ability to travel up to 20% globally.
Salary: $90,000 - $120,000 per year based on experience.
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