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About the role:

Reporting to the Head of Clinical Operations, you will be responsible for the direction and management for Owkin’s quality assurance function for clinical operations and clinical development. You will work with senior colleagues at Owkin to lead the growth of a QMS that supports the clinical-stage development of potential medicinal products.

Externally, you may be dealing with one or more contract auditors, contract GxP specialists and Quality system administrators.

In particular, you will be responsible for:

Quality Assurance Direction:

• Develops and improves existing quality processes to cover global sponsor obligations in accordance with GCP, GLP and GMP for investigational medicinal products (QMS)
• Works with Regulatory Affairs to ensure that the QMS is aligned with Owkin’s Regulatory Intelligence Process and to ensure that QA activities are undertaken in compliance with relevant laws, regulations and guidelines for clinical trial conduct
• Defines a practical approach to regulatory expectations for a critical-to-quality focussed QMS
• Defines and implements Owkin Quality Assurance activities that
  • support clinical-stage vendor qualifications and vendor oversight
  • for GLP activities – are aligned to OECD guidance on the sponsor role
• Defines and implements deviations and CAPA management policies
• Defines Owkin policies on handling any detected fraud or misconduct during clinical trial conduct or any serious breach of GCP or of clinical trial regulations
• Defines Owkin process for implementation of Urgent Safety Measures

Quality Assurance Management

• • Develops and oversees a QA team which may include internal and contract staff and expert GxP consultants, to be able to:
    • Maintain the QMS (policies and SOPs)
    • Deliver the company’s GCP and GMP for IMP training programme
    • Manage project audit plans and audits
    • Provide advice to Owkin colleagues
    • Manage a programme of internal process audits and, as relevant, vendor audits
    • Train Owkin colleagues in deviations handling and CAPA
    • Host regulatory inspections at Owkin including preparation and follow-up
  • Coordinates QA activities for the manufacture and supply of IMP for each clinical trial that are undertaken by appropriately GMP-qualified personnel
    • Ensures QA activities are conducted and reported according to Owkin SOPs
    • Maintains highly confidential audit files
    • Maintains company QA records such as audit registers, CAPA registers
    • Monitors CAPA completion
    • Presents and reports compliance metrics to senior management

Position is based in our Paris or London Office or remotely in Europe

About you

Essential to have:

• Bachelor’s degree or equivalent
• Extensive and proven experience in the Biotech, pharmaceutical, or CRO including several years in QA management
• Deep knowledge of ICH guidance for clinical trials
• Strong understanding of:
• the relationship between ICH GCP and territorial GCPs and clinical trial regulations (e.g. FDA, EU CTR)
• the relationship between GxPs in medicines development: GLP, GMP for IMP and how these relate to commercial GxPs such as GMP, GDP, GPvP
• the similarities/differences between interventional and non-interventional trials
• Past success in building/developing a QMS
• Able to manage multiple priorities
• Keen collaborator and communicator
• Experienced in hosting regulatory inspections

Nice to have:

• Knowledge of the regulations/process for applying for a medicinal product marketing authorisation
• Knowledge/experience of ISO 14155; ISO 27001; ISO 13485 a bonus

Please submit your CV in English