QA Auditor II

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 include some of the following:

• 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 mitigate quality issues and risks through the appropriate quality governance pathways.
• Review and approve, or provide quality recommendations on, documentation required to support batch disposition/release activities within the scope of the engagement and applicable authorization.
• Ensure documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived in accordance with applicable requirements.
• Support third-party selection, qualification, approval, and maintenance of approval status, as appropriate to the assigned scope.
• Participate in third-party audit planning, preparation, execution, response follow-up, and CAPA oversight, as applicable.
• Provide quality support for product or process transfers between client and third parties and for other assigned external manufacturing activities.
• Develop, implement, and improve effective processes and procedures within Quality R&D Third Party, and contribute to cross-functional process improvement initiatives.
• Provide training, education, guidance, and quality advice to business partners and third parties on relevant quality and compliance expectations.

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Pharmacy, Science, Engineering, or a related discipline, or an equivalent level of knowledge, understanding, and hands‑on GMP experience in the pharmaceutical environment.
• At least 5 years of pharmaceutical manufacturing and/or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.
• Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
• Experience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root‑cause analysis.
• Experience…