Associate Director, Facility & Validation Quality

Location: London

Reporting to: Director, Global Quality Compliance

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England.

Reporting to the Director of Global Quality Compliance, the Associate Director, Facility & Validation Quality provides Quality leadership and oversight for the facility, equipment, utilities, contamination control, and associated qualification/validation activities across the full lifecycle from concept and design through to GMP operation.

The role serves as the primary Quality business partner for the Hammersmith expansion and subsequent site operation, ensuring facility design, commissioning, qualification, validation, and operational readiness are aligned with regulatory expectations and support a compliant, risk-based, and phase-appropriate GMP environment.

The role is accountable for the Quality strategy across these areas and works cross-functionally with Facilities, Engineering, Validation, Operations, MSAT, QC and Quality Compliance to ensure the site is designed, qualified, and operated in a state of control.

The role also ensures the site Contamination Control Strategy (CCS) and sterility assurance requirements are defined, implemented and maintained through effective cross-functional partnership and use of specialist SMEs where required.

• Own the Quality strategy for facility, equipment, utilities, and associated infrastructure across design, commissioning, qualification, validation and GMP operations.
• Act as the primary Quality business partner for the Hammersmith facility and subsequent operational lifecycle
• Ensure facility-related Quality decisions are phase-appropriate, risk-based, inspection-ready and aligned with the path for licensure.
• Provide Quality review and approval, as applicable, for GMP-impacting design and validation deliverables including URBs, URSs, CCS documents, Quality Risk Assessments, validation / CQV strategies, qualification documentation, and change controls.

• Provide Quality oversight for commissioning, qualification and validation of facility, equipment, utilities, and associated GxP digital systems (CSV).
• Ensure qualification and validation strategies are risk-based, consistent, and aligned with intended use, licensure requirements and maintenance of the validated state.
• Provide Quality oversight for facility-related systems such as BMS, EMS and SCADA, including CSA / CSV, data integrity, change control, and lifecycle controls.
• Review, challenge and approve, as applicable, validation strategies, risk assessments, protocols, reports, deviations, and change controls to ensure they remain proportionate, defensible, and inspection-ready.

• Lead Quality oversight of the Contamination Control Strategy (CCS), including development, implementation, lifecycle management, and periodic review.
• Ensure sterility assurance requirements are embedded across facility design, qualification, and operation, in partnership with relevant SMEs.
• Provide Quality leadership on cleanroom classification rationale, environmental monitoring strategy, cleaning / disinfection expectations, and contamination control risk assessments.
• Ensure contamination control principles are translated into clear, practical, and effective requirements for site start-up and routine operation.

• Lead quality engagement across Facilities, Engineering, Validation, MSAT, Operations, QC and QA to support facility delivery and GMP start-up.
• Represent Quality in project governance, design reviews, readiness planning, and facility-related inspection preparation.
• Partner with internal and external stakeholders, including Kyowa Kirin and specialist vendors / consultants, to ensure timely and compliant, outcomes.
• Influence and align diverse stakeholders, balancing technical, compliance, and…