Manager, Quality Compliance

Location: London, UK

Reporting to: Associate Director, Global Quality Compliance

Job Summary

The position of Manager, Quality Compliance, reporting to the Associate Director, Global Quality Compliance, is based in the Hammersmith, London office, UK. In this role, the incumbent is responsible for ensuring that fully robust and Fit-for-Purpose GxP compliant quality system processes are maintained across the organization.

The incumbent will engage with all team members within Global Quality and other GxP functions within Orchard Therapeutics. The primary activities include overseeing the compliance and effectiveness of the quality management system, identifying and leading quality improvement projects, and liaising across GxP functions as a primary contact and source for expertise for Quality Compliance related topics.

Key Elements and Responsibilities

Primary Responsibilities

· Collaborate with the wider Global Quality team to maintain / improve the overall compliance, efficiency and effectiveness of QMS & GxP processes.

· Provide expertise, draft, review and/or approve GxP documents as the Quality compliance SME.

· Generate metrics, and support record owners and QA reps with record progression, driving a proactive and compliant quality culture.

· Chair the weekly change review board (CRB) and drive process improvements.

· Create and/or revise Quality policies, procedures and work instructions to provide an efficient and compliant cGxP QMS.

· Identify areas to improve GxP training to develop and/or deliver training across GxP functions to drive the quality culture at Orchard.

· Manage the internal audit program to risk based methodologies and lead internal audits where required.

· Perform external audits as required.

· Manage the product complaint process, perform monthly reconciliations, and participate in recalls / mock recalls as required.

· Lead and/or support GxP processes / activities including Quality Committees, Quality Escalations, Risk Governance Board, Regulatory Intelligence, Inspection Readiness.

· Business process owner for the electronic Quality Management System, including the provision of support with system activities, as required.

· Support Document Management and Training Management processes.

· Other activities as required by the Global Quality team.

Project Based

· Proactively identify and implement areas for improvement across the Quality Management System

· Lead and/or support company-wide Quality Projects in alignment with the annual quality plan to improve the overall quality management system and quality culture.

· Support the implementation of the new Veeva eQMS.

· Identify and contribute towards areas for continuous professional development personally and within the organization.

Requirements

Required Knowledge and Skills

· Extensive knowledge and understanding of GxP principles, ICH guidelines and applicable EU/UK/US regulatory requirements

· Experience and expertise in the application of quality risk management methodologies within the pharmaceutical/biotech industry.

· In-depth knowledge of data integrity requirements and demonstrated ability in identifying areas for improvement for data integrity within organizations.

· Quality management / compliance experience and expertise in ATMP development or manufacturing is a strong asset.

· Experience in working with paper-based and electronic QMS.

· Experience with and/or an understanding of CSV is an asset.

· Excellent organizational, time-management and communication skills.

· Ability to operate in a multi-disciplinary environment with competing priorities.

· Ability to lead / support projects both independently and within teams.

· Strong ability to engage and influence internal and external stakeholders.

· Proactive, enthusiastic, resourceful, and results orientated.

Education

· BSc or equivalent in a relevant scientific discipline.