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

· Serve as the Business Process Owner and primary point of contact for Orchard's eQMS and relevant quality processes.

· Perform routine administration of the eQMS system, ensuring smooth operation and prompt troubleshooting when issues arise.

· Participate in software lifecycle management of eQMS, including system implementation, upgrades, periodic reviews, decommissioning, and data migration.

· Be a Subject Matter Expert (SME) in key quality processes, including document management, training management, change management, deviation management, and CAPA/continuous improvement.

· Develop and maintain policies, procedures, and training materials in compliance with regulatory expectations and internal requirements.

· 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

· Proactively identify opportunities to drive continuous improvement within the Quality department and across the business.

· Lead and support strategic projects, ensuring on-time delivery, in alignment with corporate and departmental goals.

· 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.

· Lead and/or support internal and external audits, ensuring smooth execution and follow-up.

· Participate in inspection activities, including inspection readiness, management, and post-inspection follow-up.

· Strive for excellence in all deliverables by consistently producing high-quality results; and actively promoting a quality culture within the organisation.

· Positively contribute to a high-performing team by building trust and supporting each other's growth and development.

Required Knowledge & Skills

· Experience in GxP eQMS implementation and administration.

· Knowledge of US FDA 21CFR Part 11 and EU Annex 11 requirements for validated electronic systems and data integrity requirements.

· Demonstrated ability to interact effectively with internal and external stakeholders at all organisational levels.

· Proficiency in both written and verbal communication, with strong presentation skills.

· Proven capability in solution deployment and project management, ensuring smooth execution under tight timelines.

· Energetic, self-motivated, and organised, accustomed to working in a deadline-focused, result-driven environment.

· Ability to operate effectively in a dynamic, multi-disciplinary environment.

· Proactive, enthusiastic, resourceful, and results orientated, with a strong focus on continuous improvement.

· Working experience in ATMP GMP environment is a strong asset.

Education

· BSc or equivalent in a relevant scientific discipline.