Location: London, England
Reporting to: Director, Global Quality Compliance
Job Summary
Reporting to the Director of Global Quality Compliance, the System & Project Specialist, Quality Compliance serves as the Business Process Owner for Orchard's electronic Quality Management System (eQMS). The role manages eQMS-related processes including document management, training management, and other key quality processes. In addition, the incumbent will lead and support strategic, cross-functional quality initiatives, driving continuous improvement and ensuring consistent quality and compliance across the business. The ideal candidate will be proactive, resourceful, with a can-do attitude, always striving for consistent high-quality outputs.
Key Elements And Responsibilities
eQMS Management
1. Serve as the Business Process Owner and primary point of contact for Orchard's eQMS and relevant quality processes.
2. Perform routine administration of the eQMS system, ensuring smooth operation and prompt troubleshooting when issues arise.
3. Participate in software lifecycle management of eQMS, including system implementation, upgrades, periodic reviews, decommissioning, and data migration.
4. Be a Subject Matter Expert (SME) in key quality processes, including document management, training management, change management, deviation management, and CAPA/continuous improvement.
5. Develop and maintain policies, procedures, and training materials in compliance with regulatory expectations and internal requirements.
6. Monitor and report on key performance indicators (KPIs) for eQMS processes, proactively identifying areas for continuous improvement to enhance compliance, effectiveness, and efficiency.
Quality Project Management
1. Proactively identify opportunities to drive continuous improvement within the Quality department and across the business.
2. Lead and support strategic projects, ensuring on-time delivery, in alignment with corporate and departmental goals.
3. Assist in the qualification, validation, and oversight of Orchard's and key vendor's GxP computerised systems, ensuring compliance with regulatory standards, industry best practices, and Orchard requirements.
4. Lead and/or support internal and external audits, ensuring smooth execution and follow-up.
5. Participate in inspection activities, including inspection readiness, management, and post-inspection follow-up.
6. Strive for excellence in all deliverables by consistently producing high-quality results; and actively promoting a quality culture within the organisation.
7. Positively contribute to a high-performing team by building trust and supporting each other's growth and development.
Requirements
Required Knowledge & Skills
1. Experience in GxP eQMS implementation and administration.
2. Knowledge of US FDA 21CFR Part 11 and EU Annex 11 requirements for validated electronic systems and data integrity requirements.
3. Demonstrated ability to interact effectively with internal and external stakeholders at all organisational levels.
4. Proficiency in both written and verbal communication, with strong presentation skills.
5. Proven capability in solution deployment and project management, ensuring smooth execution under tight timelines.
6. Energetic, self-motivated, and organised, accustomed to working in a deadline-focused, result-driven environment.
7. Ability to operate effectively in a dynamic, multi-disciplinary environment.
8. Proactive, enthusiastic, resourceful, and results orientated, with a strong focus on continuous improvement.
9. Working experience in ATMP GMP environment is a strong asset.
Education
1. BSc or equivalent in a relevant scientific discipline.
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