Associate Director, Facility & Validation Quality
£27.1 - £31.7 per hourEstimated
Full-time
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. Job Summary
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
Required Knowledge & Skills and Experience
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. Job Summary
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.
- 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 operational perspectives to drive effective decisions.
- 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, 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.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Facility & Validation Quality in London vacancy
- £61k - £79k per annumEstimated...Location : London Reporting to : Director, Global Quality Compliance Orchard Therapeutics, a Kyowa Kirin company, is a global... ...Reporting to the Director of Global Quality Compliance, the Associate Director, Facility & Validation Quality provides Quality leadership and...QualityFull-time
£67.9k - £126.1k per annum
...Associate Director, Statistical Programming Salary Range: £67,900.00 - £126,100.00 Job Description... ...of programmers, driving innovation, quality, and efficiency across complex clinical... ...for timely and quality development and validation of all statistical programming...QualityHybrid workingRemoteFlexible hours- £60k - £80k per annumEstimated...with serious diseases. We are seeking an Associate Director, PV Case Operations to join our Global... ..., Individual Case Safety Report (ICSR) quality governance, and inspection readiness... ...quality standards covering narrative, case validity, and source document reconciliation....QualityFull-timeHybrid working
- £64k - £84k per annumEstimated...About the role: As Associate Director Statistical Programming you will be responsible for working... ...or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC... ...requirements Hands-on review, validation, and troubleshooting of SAS/R programs...QualityFull-time
- £125k - £165k per annumEstimated...to meet you. WHAT YOU'LL DO The Associate Director, AI Success is a senior individual contributor... ...clearly articulating customer needs, validating product hypotheses, and contributing... ...and case studies. Maintain high-quality account documentation, health tracking,...QualityHybrid workingOn-siteRemoteFlexible hours
- £79k - £105k per annumEstimated...awaits you at WSP: A little more about your role... ~ As an associate director electrical engineer you will be taking a leading role in a... ...regular team meetings to discuss resourcing, staff issues, H&S, quality, training & development & all other relevant issues, including...QualityFull-timePart-timeHybrid workingOn-siteWork from homeFlexible hours
- £67k - £86k per annumEstimated...ensure compliance of the engineering deliverables to the standards (quality) Coordinate the Quality aspects of the mechanical sub-systems... ...CDM, CSM-RA and interoperability), and Verification and Validation (V&V) technical assurance Promote sustainable design and development...QualityFull-timeOn-site
- £59k - £78k per annumEstimated...Operations, Human Biological Sample Management, Data Management, Quality, Regulatory, Commercial, and Finance, as well as external... ...development, including direct contributions to analytical and clinical validation studies Hands-on experience with Microsoft Project or...QualityFull-timeHybrid workingOn-siteRemote
- £54k - £72k per annumEstimated...Employment Type: Full‑time | Regular, Hybrid, #LI-hybrid Location: London (The Westworks) or Dublin (NOCC) The Associate Director, Clinical Quality Assurance (QA) will provide Quality oversight for the end-to-end clinical process for the clinical trials under responsibility...QualityPermanentFull-timeHybrid working
- £64k - £84k per annumEstimated...Associate Director, Digital Operations Location: London, United Kingdom Hybrid Working: 3... ...with experience querying, analysing, and validating large operational datasets. Excellent... ...efficiency, scalability, and service quality across AMRA's global digital administration...QualityPermanentFull-timeHybrid workingOn-site
- £61k - £78k per annumEstimated...a passion for data centres? AECOM is on the lookout for an Associate Director Data Centre Mechanical Engineer to join our team in Sydney! This... ...on time and within budget while maintaining the highest quality standards. Client Engagement : Build and maintain strong relationships...QualityFull-timeHybrid workingOn-siteRemoteRelocation
- £63k - £81k per annumEstimated...business and technical requirements. Define data models, workflows, validation rules, governance processes, and integration approaches.... ...and technology stakeholders to understand data governance, data quality, and master data requirements. Translate business requirements...QualityPermanent
- £45k - £60k per annumEstimated...Associate Director Clinical Quality Assurance Location: London, United Kingdom Job Type: Full-time Job ID: 10151 About the role: As an Associate Director Clinical Quality Assurance at BioNTech, you play a pivotal role in ensuring the quality and compliance...QualityFull-time
- £110k - £141k per annumEstimated...are looking for an experienced Electrical Associate Director to join us! You will be responsible for driving the technical excellence, quality, and mentoring teams while shaping... ...commissioning, and handover. Define and validate power architectures (utility intake, MV/...QualityLong-term contractFull-timeHybrid workingOn-siteRemote
- £57k - £74k per annumEstimated...manage senior client relationships, oversee quality of delivery, support new business and act as a trusted deputy to the Founder & Director. You will be responsible for ensuring... ...professional, likely already operating at Associate Director, Senior Account Director, Client...Quality
£110k - £150k per annum
...opportunity with its Aviation team, which is looking for a Senior Associate or Director to help to shape one of the UK's most exciting Aviation... ...Disputes and/or Regulatory solicitor, who is looking for high-quality work, genuine responsibility and a supportive culture with real...QualityPermanentFixed-term contract- £56k - £73k per annumEstimated...Associate Director Inspection Management (GCP) Job Requisition ID: R38901 Location: Uxbridge Time Type: Full time The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that...QualityFull-time
- £55k - £73k per annumEstimated...within multidisciplinary teams. Strong report writing, verbal and presentation skills and able to review the work of others to ensure quality. Experience in commercial coordination and project management. Able to prioritise and work effectively under pressure. Good...QualityFull-timeOn-siteFlexible hours
- £57k - £73k per annumEstimated...hear from you. Role Overview We are seeking an experienced Associate Director to help shape and scale our growing Policy & Access practice... ...for pharmaceutical and biotechnology clients. Provide high-quality strategic counsel on healthcare policy, market access and...QualityLong-term contractImmediate start
£92k - £100k per annum
...you a bright and ambitious individuals ready to step into an Associate Director role and build a successful career in M&A tax? We have an exciting... ...diligence meetings, analysis, and reporting to ensure high-quality, robust outputs ahead of final partner or director review....Quality- £76k - £99k per annumEstimated...Associate Director, Restructuring and Insolvency Interpath London, United Kingdom Interpath is an international and fast-growing advisory... ...advice Lead and manage engagements to scope, timeline, quality and budget, in line with Interpath’s engagement management standards...QualityFull-time
£70k per annum
...Associate Director – Infrastructure Planning Key Points Lead role in a growing infrastructure planning team Hybrid working with 2 days... ...respected consultancy with a strong reputation for delivering high–quality planning solutions. Our team works exclusively on complex NSIP...QualityHybrid workingOn-siteFlexible hours- £86k - £111k per annumEstimated...Relation is offering an outstanding opportunity for an experienced Associate Director/Director of Medicinal Chemistry to help drive our growing... ...you will translate cutting-edge biological insights into high-quality clinical candidates, working at the intersection of science...QualityFull-time
- £51k - £67k per annumEstimated...international architecture and design practice is seeking an Associate Director – Sustainability to join its growing London team. This is an... ..., BREEAM, LEED, NABERS and Fitwel Prepare and present high–quality sustainability reports, strategies and technical documentation...QualityHybrid workingWork from home
- £59k - £78k per annumEstimated...aren’t words that are usually associated with a job. But working at... ...'re looking for an Associate Director of Clinical Data Management to... ...single trial Leading Data Quality Review meetings, ensuring the... ...shifts onsite at your assigned facility. Site-by-design roles may be...QualityFull-timeHybrid workingRemoteShift work
- £57k - £74k per annumEstimated...Description General Summary: The Pricing Analytics & Insights, Associate Director, provides senior, end-to-end leadership of international... ...leader to improve data literacy, tool usage and decision quality across regional and local teams. Influence senior governance...QualityFull-timeHybrid workingRemote5 days/week
- £60k - £77k per annumEstimated...Description Summary We are looking for a Global Labelling Associate Director, Content (Oncology) to contribute to the development and delivery... ..., prioritisation, and attention to detail to deliver high-quality work within timelines. Commitment to Diversity and Inclusion...QualityFull-timeHybrid workingOn-siteRemote
£400.42 per day
...commissioning strategies are evidence based. ⦁ pathway redesign. ⦁ development and implementation of relevant service and quality specifications and associated contracting mechanisms. ⦁ development and implementation of performance and outcome measures, and relevant...QualityFull-timeInterimImmediate start- £55k - £71k per annumEstimated...Germany; Munich, Germany Work type: Full time Job ID: 11320 About the Role: As Associate Director Audit Management, you will play a pivotal role in ensuring the quality and compliance of BioNTech’s clinical trials and processes. As part of the Global Development...QualityFull-timeRemote
- ...opportunity has arisen for an experienced and highly motivated Associate Director of Contracts to join a large and progressive NHS organisation.... ...operational colleagues, you will support the delivery of high-quality, financially sustainable services aligned to organisational...QualityHybrid workingFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Facility & Validation Quality. Be the first to apply!
Related searches
- associate portfolio manager London
- medical director associate director ophthalmology London
- associate director of finance London
- associate director qa London
- associate director quantity surveyor London
- associate director data science London
- associate director business development London
- senior associate director London
- associate director London
- architectural associate director London