QA Auditor II

About the role

An opportunity has arisen for a Third Party Quality Lead to support the Quality R&D Third Party organization. The worker will provide quality oversight for external third parties supporting GMP manufacture of active pharmaceutical ingredient (API), cell banking (CB), drug substance (DS), and drug product (DP) for R&D programs. The successful candidate will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, quality, and quality agreement requirements. The role also provides the opportunity to apply third-party quality management expertise in a cross-functional R&D environment.

Responsibilities

• Act as the primary day-to-day quality contact for assigned third parties and projects, working with internal stakeholders involved in activities contracted to those third parties.
• Monitor and support management of third-party quality performance and compliance with applicable standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements.
• Coordinate and support quality governance meetings with assigned third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.
• Draft, coordinate, review, maintain, and support approval of quality agreements and related quality documentation, as applicable.
• Review and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements.
• Identify, assess, document, communicate, mitigate, and escalate quality issues and risks through the appropriate quality governance pathways.