Quality Sr. Specialist, Vendor Management (contract) 25416

Job Description

The Senior Quality Specialist, Vendor Management works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures and to ensure compliance with applicable regulatory requirements.  The Senior Quality Specialist completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes.  This role is responsible for providing coordination and support of Vendor Management processes within CMC Quality.  

This position reports to: Director, Small Molecule CMC Compliance–Vendor Quality Management 

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES: 

Key Leadership Skills: 

• Cross-functional collaboration 

• Results driver 

 

Key Knowledge/ Skills and Competencies: 

• GxP knowledge with global understanding /application of phase appropriate regulations 

• Working knowledge of: 

• Compliance GMP/GDP regulations-applicable global regulations for modalities such as medical device, solid oral dose, biologic, gene therapy, etc. 

• Phase appropriate requirements (based on product lifecycle) 

• Materials, Vendor and Audit Management processes 

• Quality Management Systems and associated information systems (software/systems) 

• Technical writing  

• Attention to detail  

• Communication and Relationship management skills 

• Flexibility/adaptability 

• Analytical thinking 

• Continuous improvement 

• Veeva experience 

 

KEY RESPONSIBILITIES: 

• Ensures that the Approved Vendor Lists are kept current and that the information within is accurate. 

• Oversee Quality and Compliance of Vendor Profile Records across GDP and GMP vendors. 

• Partner with internal customers (AIM, business stakeholders and Operational QA). 

• Update Vendor Profiles as needed. 

• Monitor and facilitate changes with External Partners. 

• Ensures that all the documentation associated to the Vendor Management program; risk assessment reports, Approved Vendor Lists, Vendor Profile Records, contact lists, GMP certificates, supporting documentation, etc. is uploaded into the applicable QMS and documentation repositories as applicable. 
• Supports metrics activities for the Vendor Management program. 

• Consults with other QA functions team members and Supply Chain stakeholders to complete the Supply Chain Maps; ensure that the AVL is keep updated and aligned with the Supply Chain Maps. 

• Verifies vendor addresses to ensure the Approved Vendor List (AVL) is accurate to support regulatory submission activities. 

• Ensures vendor Scorecards are completed and up to date. 

• Coordinates ongoing meetings with customers to collect performance feedback and ensure the completion on time of the Vendor’s performance dashboard. 

• Coordinate Vendor Change Notification (VCN)meetings and initiate Change Requests in VeeQMS.  

• Monitor the Vendor Management centralized eMail inbox for VCN 

• Create Change Request in VeeQMS 

• Escalate issues, if required 

• Provide support for Change Management related to Vendor Quality Management. 

• Provide support for Deviations and CAPA activities related to Vendor Quality Management. 

• Ensures that the SOPs, SD’s and WI associated to the Vendor Management Program are current. 

• Identifies risks and communicates gaps to applicable Quality System Owner(s). 

• Serves as a liason between the business, Sourcing groups and QA functions for the selection, onboarding and monitoring of vendors. 

• Assist with authoring of Risk Assessment and Mitigation plans for High Risk and Restricted Vendors. 

• Serve as a liaison for communication Vendor Excipient Risk Assessment and Reduced Review Process. 

• Develops and implement initiatives to improve the Quality Agreement and Vendor Management processes.  

• Other tasks as assigned by Management. 

 

PREFERRED QUALIFICATIONS: 

• M.S. (or equivalent degree) and 0 –3 years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 5 –8 years of relevant work experience, or relevant comparable background 

• Experience with Vendor /Audit management in the GxP space