QA Specialist - Supplier Quality
Core
Ensure quality and compliance of materials, equipment, and services for monoclonal antibody programs by overseeing the full supplier lifecycle.
Role type
Supplier Quality Management Specialist
Builds
Reliable supply chain for biopharmaceutical development and manufacturing
Domain
Biopharmaceuticals / Life Sciences / Regulatory Compliance
Deliverable
client delivery
Required skills
Supplier qualification and lifecycle management, Quality Agreement negotiation, Quality event management (deviations, complaints), Risk assessment and mitigation, Regulatory compliance (cGMP, FDA, EMA, etc.), Audit preparation and execution, Data integrity
Preferred skills
Experience with electronic Quality Management Systems (e.g., Veeva), ERP systems (e.g., SAP), Continuous improvement initiatives
Technologies
Veeva, SAP
Responsibilities
Selecting, qualifying, and managing a portfolio of suppliers; Partnering with cross-functional teams on supplier selection and management; Negotiating and maintaining Quality Agreements; Managing supplier quality events; Performing quality risk assessments; Monitoring and reporting quality performance metrics; Keeping suppliers ready for regulatory and internal audits
Seniority
Mid-Senior, hands-on IC