Quality Systems Specialist III

This is a fully remote position, open to applicants in California.

📋 Description

• Gather and arrange quality data and metrics to facilitate Quarterly Executive Management Reviews.

• Create professional PowerPoint presentations utilizing information and data from global business and Quality stakeholders.

• Oversee and coordinate inputs, timelines, and deliverables from various cross-functional contributors.

• Work collaboratively with global Quality teams to ensure timely and precise completion of Management Review deliverables.

• Evaluate Quality System reports, dashboards, and metrics in Veeva QMS to assist in executive-level reporting and presentations.

• Examine and summarize quality trends and data for discussions during management reviews.

• Offer general support for QMS processes, including Deviation Management, CAPA, Document Control, and Change Control.

• Monitor action items and follow up with stakeholders as necessary.

• Assist with continuous improvement and other Quality Systems activities as assigned.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Quality, Engineering, or a related discipline.

• Over 5 years of experience in Quality Systems and/or Quality Management within the pharmaceutical, biotechnology, medical device, or life sciences sectors.

• Proven experience in supporting Quality Management Reviews / Management Review processes.

• Required hands-on experience with Veeva QMS.

• Proficient in Microsoft PowerPoint with a background in developing executive-level presentations.

• Familiarity with Quality metrics, dashboards, and management reporting.

• Strong organizational abilities to manage multiple deliverables and deadlines effectively.

• Capability to coordinate efficiently with global and cross-functional stakeholders.

• Exceptional written and verbal communication skills.

• Experience with Document Control, Deviations, CAPA, and Change Control.

• Background in a GxP/GMP-regulated environment.

• Experience in presenting or preparing materials for senior/executive Quality leadership.

• Familiarity with Veeva Quality dashboards and reporting.

• Experience in supporting global Quality organizations.

• Willingness to work during PST Hours.

🏝️ Benefits

• Medical

• Paid Sick Leave

• 401 (k)