Supplier Quality Senior Specialist

Position Summary

The Supplier Quality Senior Specialist supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site, including vendor and material qualification/management, change management, and supplier non-conformance reporting and resolution.

• Qualify and manage GMP/GDP vendors: assess vendors, create/revise quality agreements, maintain Approved Vendor List.
• Manage lifecycle of starting materials: material qualification/requalification, reduced testing, direct dispense.
• Assess supplier change notifications (SCN) and complete required actions in the BMS change management system.
• Support deviations, Supplier Corrective Action Requests (SCAR), and CAPA for nonconforming vendor materials/services.
• Review SOPs, technical documents/reports, agreements, qualifications, and forms.
• Oversee on-site service vendors in collaboration with business owners and QA Operations.
• Identify quality and business continuity risks and notify management as appropriate.
• Collaborate cross-functionally; may represent the team on supplier/material initiatives and support external audits.

• B.S. in science/engineering/biochemistry or related field (or equivalent education/experience/training).
• 4+ years in a regulated biopharmaceutical environment.
• Practical knowledge of US/EU cGMP and ISO standards.
• Familiar with SAP, Veeva, Syncade.
• Strong attention to detail, accountability, collaboration; excellent written/oral communication.

• Devens, MA: $89,530–$108,490; additional incentive opportunities may apply.
• Health coverage; wellbeing programs; 401(k) and other insurance/disability/life benefits.