QA Manager, Vendor QA

Role Summary

QA Manager, Vendor QA leads the vendor management program, internal and some external audits, and operational support as needed. The role collaborates cross-functionally with Supply Chain, Manufacturing, Quality Control, Information Technology and other teams to support preclinical, clinical, and commercial product development. This is an in-person role on site at the Lexington facility with a minimum of 4 days on site.

Responsibilities

• Lead the end-to-end vendor qualification process, ensuring compliance with regulatory and company standards
• Manage the creation and revision of vendor management procedures
• Plan and conduct onsite or remote supplier audits
• Identify, assess, and mitigate supplier related risks
• Drive continuous improvement initiatives for the vendor management program
• Plan and conduct/support internal audits
• Manage quality records related to vendor management in Veeva
• Provide guidance to internal stakeholders on vendor management process
• Support supplier correction action reports (SCARs) and supplier change notifications (SCNs) processes
• Report on KPIs related to Supplier Qualifications and internal audits
• Adhoc tasks as assigned by manager

Qualifications

• Required: Bachelor’s degree with a minimum of 7 years of related experience in a Quality Assurance organization, with at least 5 years’ experience in Vendor Qualification
• Required: Experience working in a GMP environment in the pharmaceutical or biotechnology industry
• Preferred: GXP experience
• Preferred: Experience supporting both investigational phase and commercial products
• Required: Demonstrated experience conducting and managing supplier audits and related documentation
• Required: Experience conducting internal audits

Skills

• Strong understanding of vendor management process
• Conducting internal and supplier audits
• Problem Solving
• Collaboration with suppliers and internal stakeholders
• Knowledge of electronic solutions including Veeva, SmartSheets and SharePoint strongly preferred
• Ability to work independently
• Ability to travel domestically and internationally, up to 25%

Education

• Bachelor’s degree (implied by qualifications above)

Additional Requirements

• Travel domestically and internationally up to 25%