Sr. Manager, Quality Systems - Audits & CAPAs (2026-8012

Sr. Manager, Quality Systems
-Audits & CAPAs

The Sr. Manager, Quality Systems
-Audits & CAPAs is responsible for the day-to-day management and hands-on execution of Care Tria's internal audit, supplier audit, and Corrective and Preventive Action (CAPA) programs. This role manages the operational delivery of the full audit lifecycle including planning, scheduling, execution, reporting, and findings closure for internal, supplier, and third-party audits in alignment with cGMP, GDP, PDMA, and DSCSA requirements. The Sr.

Manager leads the qualification, ongoing monitoring, and periodic reevaluation of service providers to ensure continued compliance with cGMP, GDP, QMS expectations, and client requirements.

Responsible to drive continuous improvement across the Quality Management System by ensuring audit outcomes and CAPA activities strengthen operational controls, mitigate risk, and support a constant state of inspection readiness for clients and regulatory authorities. This role ensures that all quality events including deviations, distribution errors, temperature excursions, and other nonconformances—are thoroughly investigated using sound root-cause methodologies and that effective, sustainable corrective and preventive actions are implemented and closed on time.

** Must reside within a commutable distance from our Lakewood, NJ location.

• Oversee the day-to-day operational administrator of the eQMS, managing user access, workflow routing, training assignments, and system accuracy.
• Execute and manage the annual Internal Audit Plan and Supplier/Third-Party Audit Plan under the direction of the department senior management, including scheduling, conducting audits, drafting comprehensive audit reports, and driving timely closure of all audit findings.
• Develop and maintain audit questionnaires and checklists to standardize compliance assessments across all supplier and client interactions; recommend updates to the department senior management as regulations or program needs evolve.
• Manage the Investigations and CAPA process in accordance with cGMP, GDP, PDMA, and DSCSA requirements, ensuring root cause analyses are thorough and that corrective/preventive actions are assigned, tracked, and closed within approved timelines.
• Coordinate client-specific audit CAPAs and questionnaires, ensuring responses are professional, accurate, and submitted within contractual timelines; escalate complex or high-risk client quality matters to the Associate Director. Partner with the Quality Control organization on shared quality events and investigations.
• Manage the lifecycle of QMS events, including deviations, change controls, and non-conformances, ensuring they are documented, investigated, and mitigated per approved SOPs and within required time frames.

• Directly manage, mentor, and develop QA staff within the Audits & CAPAs team, establishing clear performance goals and supporting professional development in audit and investigation competencies.
• Manage daily activities and workloads of QA staff to ensure all audit schedules, investigation timelines, corrective action plans, and compliance deadlines are met; escalate resource conflicts or program risks to the Associate Director.
• Conduct regular performance check-ins and formal evaluations; provide ongoing coaching and technical guidance to ensure staff proficiency in audit execution, root cause analysis, and CAPA writing.
• Track, trend, and compile Quality KPIs (e.g., CAPA cycle time, audit findings closure rate, overdue investigations) and prepare reporting packages for presentation to Senior Leadership at Management Review Meetings.
• Monitor team workflows daily to ensure no investigation or CAPA reaches "Overdue" status without a pre-approved extension and documented impact assessment; escalate imminent overdue items to department senior management in advance.

The above duties are meant to be representative of the position and not all-inclusive.

• Education: Bachelor's degree in Life Sciences, Supply Chain Management, or a related technical field.
• Experience: Minimum of 4–6 years in Quality…