Quality Sr. Specialist, Vendor Management (contract) 25416

We are seeking a Quality Senior Specialist, Vendor Management to support vendor oversight and compliance activities within the CMC Quality organization. This role requires a high level of independence and critical thinking to improve internal procedures, troubleshoot issues, and ensure alignment with applicable GxP regulatory requirements. The successful candidate will coordinate vendor-related processes, maintain quality documentation, and serve as a liaison between internal stakeholders and external partners to uphold the integrity of the Vendor Management program.

Key Responsibilities:

• Maintain and ensure accuracy of the Approved Vendor List (AVL) and Vendor Profile Records (VPRs) across GDP and GMP vendors.
• Partner with stakeholders across Quality, Supply Chain, and Sourcing for vendor onboarding and monitoring.
• Update and verify vendor documentation including risk assessments, GMP certificates, and contact details.
• Support audits, change management, and CAPA activities related to vendor compliance.
• Initiate and track Vendor Change Notifications (VCNs) and associated Change Requests in quality systems.
• Coordinate performance monitoring activities including vendor scorecards and feedback dashboards.
• Ensure alignment of the AVL with supply chain maps for regulatory submission support.
• Manage centralized Vendor Management email inbox and escalate issues as needed.
• Participate in risk assessments for high-risk or restricted vendors and support mitigation plans.
• Drive continuous improvement initiatives for Quality Agreement and Vendor Management processes.
• Ensure standard operating procedures, supporting documents, and work instructions are up to date and compliant.

Requirements

Qualifications:

• M.S. in a scientific or allied health field and 0–3 years of relevant experience, or
• B.S. in a scientific or allied health field and 5–8 years of relevant experience, or
• Equivalent professional background.
• Prior experience in vendor or audit management within a regulated GxP environment.
• Experience collaborating with cross-functional teams.

Required Knowledge, Skills, and Competencies:

• Strong knowledge of GxP regulations with global application across various product modalities (biologics, small molecule, gene therapy, etc.).
• Experience with vendor, audit, and materials management processes.
• Familiarity with Quality Management Systems (QMS), Veeva QMS, and documentation repositories.
• Excellent technical writing, communication, and stakeholder management skills.
• Ability to adapt, think analytically, and contribute to continuous improvement.
• Attention to detail and ability to work independently in a dynamic environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Experience with EDMS, EQMS, and ELMS preferred.

Benefits

• Contract Position