Manager, Quality Systems

Role Summary

This role supports the administration, oversight, and continuous improvement of the electronic Quality Management System (eQMS), including Deviation, CAPA, and Change Management processes. The position ensures quality records are compliant, complete, and closed within established timelines while maintaining alignment with regulatory and business requirements. In addition to process support, this role provides QMS system administration, testing, reporting, and end-user guidance to ensure the quality system operates effectively and supports inspection readiness.

Responsibilities

• Provides support for the implementation and maintenance of the quality systems program.
• Assists with the oversight of the Corrective and Preventive Action (CAPA) process to ensure CAPAs and associated records are reviewed and completed in a timely and compliant manner.
• Assists with the oversight of the Change Management program to ensure continuous compliance of the Quality System. Assist with ensuring timely completion/closure of change management records.
• Assists with the oversight of the Deviation process to ensure deviations and associated records are reviewed and completed in a timely and compliant manner.
• Provides support and training to end users for processing Deviation investigations, CAPAs and Change Management.
• Management of electronic Quality Management System (QMS) (e.g., Veeva Vault QMS), including troubleshooting issues through testing in Veeva Sandbox environment. Author, review and execution of PQ scripts within Veeva Test environment.
• Ensures quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
• Provides support for Quality System metrics, including review and identifying/addressing trends. Provides support for internal audit and regulatory inspections of quality management systems.
• Provides QMS Business Administrator support to end users (e.g. reassigning tasks, updating picklists or objects, creating reports and dashboards.)
• Other duties as assigned.

Qualifications

• Proficiency in Microsoft Excel, Word, and Outlook.
• Critical thinking skills in analyzing and exercising judgement on complex issues, guided by a thorough understanding of quality philosophy.
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.
• Skilled at effectively communicating department or area issues and results within and across functional areas.
• Able to gain cooperation of others.

Education

• Bachelor’s degree in Life Sciences or an equivalent combination of relevant education and applicable job experience may be considered. A minimum of 3 years Quality Systems experience.

Additional Requirements

• Location: Based in San Diego, CA or San Francisco, CA or Princeton, NJ. Hybrid model requires in-office three days per week.