Senior Quality System Specialist – Maternity Leave Cover

🕒 2 days ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🇬🇧 UK Skilled Worker Visa Sponsor

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Logo of Jazz Pharmaceuticals

Jazz Pharmaceuticals

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

• medical, dental and vision insurance • retirement savings plan • flexible paid vacation

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