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  • Quality Assurance Director France
  • Owkin in France, , France
  • jobs
  • 5 days ago

jobs description

This a Full Remote job, the offer is available from: France

About us

Owkin is an AI biotechnology company that uses AI to find the right treatment for every patient. We combine the best of human and artificial intelligence to answer the research questions shared by biopharma and academic researchers. By closing the translational gap between complex biology and new treatments, we bring new diagnostics and drugs to patients sooner.

Owkin has raised over $300 million and became a unicorn through investments from leading biopharma companies (Sanofi and BMS) and venture funds (Fidelity, GV and BPI, among others).

Owkin is seeking the best and brightest to join our fast-growing and dynamic team.

#LI-HB1

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

What we offer
• Flexible work organization and access to remote work
• Friendly and informal working environment
• Opportunity to work with an international team with high technical and scientific backgrounds

Recruitment Process & Security
• Please complete the form and submit your CV.
• Owkin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, gender, sexual orientation, age, color, religion, national origin, protected veteran status or on the basis of disability.
• Owkin is a great place to work. Unfortunately, being a coveted workplace means we are vulnerable to recruitment phishing scams. We urge all job seekers and candidates to be wary of potential scams. Most of these have individuals posing as representatives of prominent companies, including Owkin, with the aim of obtaining personal, sensitive, or financial information from applicants. These scams prey upon an individual’s desire to obtain a job and can sometimes “feel” like a genuine recruitment process. Some red flags are identified below. Should you encounter a recruitment process that claims to be for Owkin but is not consistent with the below, please do not provide any personal or financial information:
• Legitimate Owkin recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn.
• Communication is always through an official Owkin email address (from the @owkin.com domain), over the phone or though our applicant tracking system (Greenhouse).
• The Owkin talent team do use platforms such as LinkedIn and Job Teaser, however if you have any concern or doubt about this contact, please ask for them to send an email from @Owkin.com.
• The Owkin talent team will not solicit personal data from candidates during the application phase including, but not limited to, date of birth, social security numbers, or bank account information;
• Legitimate Owkin interviews may be conducted over the phone, in person, or via an approved enterprise videoconferencing service (Google Meets). They will not occur via Signal, Telegram or Messenger
• Owkin offers of employment are based on merit and only extended once a candidate has interviewed with members of the talent and hiring team. Offers will be extended both verbally and in written format.

If you think that you have been a victim of fraud,
• Check the identity of the talent team on LinkedIn.
• Check the existence of the position on our website https://owkin.com/hiring
• Notify Owkin's recruitment unit at this address [email protected]
• contact the following authorities:
• [FR] https://www.internet-signalement.gouv.fr/
• [UK] https://www.actionfraud.police.uk/reporting-fraud-and-cyber-crime
• [US] https://reportfraud.ftc.gov/

This offer from "Owkin" has been enriched by Jobgether.com and got a 75% flex score
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