Associate Director, Facility & Validation Quality

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.

Key Responsibilities

Facility Quality Strategy & Lifecycle Ownership

· 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.

Validation & Systems Oversight

· 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.

Contamination Control & Sterility Assurance

· 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.

Cross-Functional Leadership & Delivery

· 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 operational perspectives to drive effective decisions.

· Provide clear direction in complex or ambiguous situations, while maintaining Quality standards and pragmatic, risk-based judgement.

Operational Readiness & Inspection Support

· Support GMP operational readiness for the facility, including Quality input to SOP strategy, training readiness, governance for deviations / change control, and maintenance of the validated state.

· Ensure facility and validation decisions made during project execution remain workable and compliant in routine GMP operation.

· Act as the primary Quality lead for facility, validation, and contamination control topics during inspection readiness activities and regulatory interactions, with support from relevant SMEs as required.

Required Knowledge & Skills and Experience

· Strong knowledge of GMP regulatory frameworks, including EU GMP (EudraLex Volume 4 Part I, Part IV, Annex 1 and Annex 11), with practical application to facility design, qualification, validation and operation.

· Proven expertise in facility, utility and equipment qualification and validation lifecycle, including risk-based approaches and maintenance of the validated state.

· Solid understanding of contamination control and sterility assurance, including CCS, cleanroom classification, environmental monitoring and cleaning / disinfection strategies.

· Working knowledge of CSV/CSA and data integrity principles for facility-related systems (e.g. BMS, EMS, SCADA), aligned with current GAMP principles.

· Experience supporting or leading regulatory inspections and inspection readiness activities (e.g. MHRA, EMA, FDA), with ability to defend facility, validation and contamination control approaches.

· Strong cross-functional leadership and influencing skills, with ability to align stakeholders, challenge constructively, and drive decisions without direct authority.

· Pragmatic, risk-based problem-solving capability, with ability to navigate complexity, exercise sound judgement, and translate regulatory requirements into clear, practical solutions.

· Clear and structured communicator, able to engage both technical and non-technical stakeholders and represent Quality confidently in senior forums and inspections.

· Experience in ATMP, cell therapy, gene therapy, biologics, or similarly complex aseptic GMP manufacturing environments is strongly preferred.

· Experience working in phase-appropriate GMP environments supporting clinical manufacturing is preferred.

· Demonstrated experience supporting major facility projects, expansions, or site start-up activities from design through GMP operation is preferred, · Degree in a scientific, engineering or related discipline or equivalent industry experience in GMP-regulated environments.

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.