The Senior Quality Systems Specialist supports the administration, governance, and continuous improvement of Jazz's electronic Quality Management System (eQMS). The role partners with internal stakeholders and external vendors to maintain system compliance, reliability, and effectiveness while driving enhancements that improve the user experience and support business objectives.

Essential Functions/Responsibilities

Support the business by assuming responsibility as Business Administrator for the company digital Quality Management System (eQMS) including all functionality.

• Function as a Business Administrator of the eQMS system

• Maintain the validated state of the global eQMS, troubleshooting, investigating, and escalating issues that impact system performance. Partner with IT, Compliance, and business stakeholders to ensure timely resolution.

• Collaborate with platform vendors and Level 2 support teams to ensure timely issue resolution while maintaining appropriate cost controls.

• Provide support for Veeva Quality Suite and Jazz releases of changes to the system, ensuring the system functions as expected and all affected stakeholders are informed

• Manage the Super User group to ensure they are consistently informed of all system developments.

• Own the administration of the Good Idea Process, ensuring requests are evaluated, prioritized, and communicated to stakeholders in a timely manner.

• Analyze user feedback, identify opportunities for system enhancements, and support continuous improvement initiatives to maintain compliance and improve system effectiveness.

• Oversee the Good Idea Process to ensure that requests are properly evaluated and outcomes are communicated in a timely and efficient manner.

• Ensure that all procedural documents supporting the Business Administration role are accurate, up to-date, and in compliance with relevant standards

• Be a key member of company audit team during regulatory or customer audits

• Generate Veeva Quality Support metrics and prepare presentations suitable for Senior Management review

• Proactively look for continuous improvement opportunities within the VQS

Required Knowledge, Skills, and Abilities

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

• Minimum of 8 years of experience within the pharmaceutical, biotechnology, or regulated industry environment.

• Experience administering and supporting electronic Quality Management Systems (eQMS).

• Veeva Quality Vault Business Administrator training and certification, or equivalent experience.

• Strong understanding of GxP requirements and computerized system compliance.

• Demonstrated ability to work independently and manage multiple priorities in a fast-paced environment.

• Excellent verbal, written, and presentation communication skills.

• Proven problem-solving, stakeholder management, and continuous improvement capabilities

Required/Preferred Education and Licenses

• Typically, Bachelor’s degree in science or related discipline

• Business & Administration qualifications

• Knowledge of Quality Systems in the Pharmaceutical Industry, including digital cloud systems for Quality Management