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Braine-l'Alleud

    Asset Quality Lead - Braine-l'Alleud, België - UCB

    UCB
    UCB Braine-l'Alleud, België

    2 weken geleden

    ucb background
    Beschrijving

    Make your mark for patients

    We are looking for a Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations.

    About the role

    As part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by providing quality directions and insights that protect patients, sustain compliance, including driving inspection readiness activities aiming for real-time readiness, and preserve UCB's reputation.

    The AQL will focus on driving quality and compliance in the early and clinical development phases of UCB compounds, from candidate selection to life cycle management, at a global level and in partnership with the Early Solutions and Development Solutions organizations and external stakeholders.

    The AQL serves as a key partner for the overall early and clinical development strategy at a compound level, in support of Sr R&D Leadership to develop and shape the future portfolio strategy as well as to align for execution and implementation.

    Who you'll work with

    The responsibilities and activities of the ECDQ team span all development phases of the UCB product portfolio until the granting of marketing authorization and at a global level. The key responsibilities of our ECDQ Team are to ensure that quality systems are in place and monitored to prevent and pro-actively mitigate risks that could potentially impact the safety of patients and the quality of the data in our clinical trials. The AQL will also ensure quality strategies are developed at a Compound Level, strategic and specialty vendors are selected and operating in adherence with UCB expectations and Global Health Authority inspections are appropriately led, managed.

    What you'll do

  • Develop and maintain a strategic quality roadmap/plan to execute on specific strategic initiatives that will deliver the long-term development strategy, and to document e.g. critical to quality parameters and measures (to be) taken applicable to all development phases for the assigned compound(s), in consideration of systems applied and vendors involved.
  • Seek opportunities at a compound level aimed at establishing research/study design and vendor oversight that is fit for purpose, with focus on pro-actively ensuring the quality of downstream regulatory documentation, but also at the level of the systems and solutions applied to support developmental activities.
  • Contribute to the risk mitigation program established for UCB clinical programs, prospectively identifying critical quality risk factors, their potential impact, and developing efficient processes or solutions to manage the risks.
  • Independently plan, coordinate and execute quality activities (e.g. data review, spot checks) in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials are performed and data are generated in adherence with the study protocol, targeted endpoints and in compliance with regulations.
  • Review and coordinate the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs.
  • Leverage internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance.
  • Conduct moderate to complex analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.

    • Interested? For this role we're looking for the following education, experience, and skills:

  • Master's degree in relevant scientific or healthcare related field.
  • 10+ years of experience working in the (bio)pharmaceutical industry with a minimum of 5+ years in the early and/or clinical development operational and/or quality domain.
  • Proficient in GCP regulations, applicable technical aspects, and regional specificities.
  • Ability to translate regulatory and quality expectations into operations based on experience and knowledge of quality principles.
  • Expertise in Neurology, Immunology and Advanced Therapeutic Medicinal Products preferred.
  • Proven track record in GCP quality auditing, inspection management and clinical quality management.
  • Demonstrated ability to manage quality and compliance issues respectfully, with diligence, rigor, within timeliness, and in all transparency.
  • Experience presenting complex projects and issues in a clear succinct manner.
  • Must demonstrate excellent planning, organizational, presentation and training skills.
  • Experience in other GxP areas (GLP, GVP, GMP, GDP) is an asset.

    • Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

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