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About the Role

Provides Quality leadership and oversight for facility, equipment, utilities, contamination control, and associated qualification/validation activities across the full lifecycle. Serves as the primary Quality business partner for facility operations, ensuring alignment with regulatory expectations and supporting a compliant, risk-based GMP environment.

Responsibilities

• 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 for GMP-impacting design and validation deliverables.
• 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.
• Review, challenge and approve validation strategies, risk assessments, protocols, reports, deviations, and change controls.
• 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.
• 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 to ensure timely and compliant outcomes.
• Influence and align diverse stakeholders, balancing technical, compliance, and operational perspectives.
• Provide clear direction in complex or ambiguous situations, while maintaining Quality standards and pragmatic, risk-based judgement.
• 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.

Requirements

• 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.

Skills

• Facility Quality Strategy
• Lifecycle Ownership
• Validation & Systems Oversight
• Contamination Control & Sterility Assurance
• Cross-Functional Leadership
• Operational Readiness
• Inspection Support
• GMP Regulatory Frameworks
• Facility, Utility and Equipment Qualification and Validation
• Contamination Control and Sterility Assurance
• CSV/CSA and Data Integrity
• Regulatory Inspections
• Leadership
• Influencing
• Problem-Solving
• Communication

Location

• London

Work Type

• Full-time

Experience Level

• Associate Director
• Senior Level

Education Level

• Degree in a scientific, engineering or related discipline or equivalent industry experience in GMP-regulated environments.

About the Company

• 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.