QA Manager, Vendor QA

QA Manager, Vendor QA

Work Location: Middlesex County, Massachusetts

Summary:

The QA Manager, Vendor QA is responsible for leading the vendor management program, conducting internal and external audits, and providing operational support for quality assurance activities. This role collaborates with cross-functional teams to support preclinical, clinical, and commercial product development, ensuring compliance with regulatory standards and continuous improvement of vendor-related processes.

Responsibilities:

• Oversee the full vendor qualification process, ensuring adherence to regulatory and internal standards.
• Develop, update, and maintain vendor management procedures and documentation.
• Plan and execute supplier audits, both onsite and remotely, to assess compliance and performance.
• Identify and mitigate risks associated with suppliers, implementing corrective actions as needed.
• Drive initiatives for continuous improvement within the vendor management program.
• Conduct and support internal audits to ensure ongoing compliance with quality standards.
• Manage and maintain quality records related to vendor management using electronic systems.
• Provide expert guidance to internal teams on vendor management processes and support supplier corrective action and change notification processes.

Qualifications:

• Bachelor’s degree required.
• Minimum of 7 years of experience in a Quality Assurance organization, including at least 5 years in vendor qualification.
• Experience in a GMP environment within the pharmaceutical or biotechnology industry; GXP experience is a plus.
• Background supporting both investigational phase and commercial products strongly preferred.
• Proven experience conducting and managing supplier and internal audits, including related documentation.
• Strong understanding of vendor management processes and risk mitigation strategies.
• Proficiency with electronic quality management systems such as Veeva, SmartSheets, and SharePoint preferred.
• Excellent problem-solving skills and ability to work independently.
• Strong collaboration skills with both suppliers and internal stakeholders.
• Ability to travel domestically and internationally up to 25%.

Published Category: Quality & Validation