QA Auditor II

Job Description

Job Summary:

• 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.

Duties & Responsibilities:

• 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 escalate 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 Product 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 Product.
• 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 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.

Required Qualifications:

• 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 working with external manufacturing organizations, suppliers, service providers, or other third parties.
• Ability to make sound, risk-based quality decisions and escalate issues appropriately.
• Proficient working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.

Preferred Qualifications:

• If you have the following characteristics, it would be a plus:
• Experience providing quality oversight for contract manufacturing organizations supporting API, cell banking, drug substance, drug product, or investigational medicinal products.
• Knowledge of the pharmaceutical R&D lifecycle, including clinical development manufacturing and technology transfer.
• Experience with batch documentation review and disposition/release support.
• Experience with quality agreements, third-party quality governance, quality performance monitoring, and supplier qualification.
• Ability to work independently, manage competing priorities, and consistently deliver agreed outputs in a matrixed and deadline-driven environment.
• Excellent written and verbal communication skills, with the ability to build effective working relationships and influence internal and external stakeholders.
• Strong attention to detail, analytical thinking, problem identification, and problem-solving skills.
• Experience working effectively with cross-functional and geographically dispersed teams and supporting continuous improvement initiatives.