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Quality Process Data Owner -14451

Quality Process Data Owner -14451

RandstadEigenbrakel, Waals-Brabant, Belgium
2 dagen geleden
Functieomschrijving

Quality Process Data Owner - 14451

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Consultancy Project from 03 / 2025 to 03 / 2026

Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.

Responsibilities :

  • Provide stewardship and functional management to lead the implementation of strategies for all GxP and non-GxP QA processes (Veeva Source Quality QMS).
  • Be the process data owner for Source QMS, ensuring global collaboration and compliance.
  • Take a leadership role in bringing together the QMS key users periodically.
  • Accountable for the inspection and audit readiness of the platform under the scope of the Quality Digital.
  • Monitor industry trends and discuss possible impacts on internal strategies.
  • Drive long-term strategic planning for the platform in collaboration with stakeholders.
  • Proactively seek continuous improvement and develop best practices in organization and customer focus.
  • Establish and build a network with key stakeholders and external partners related to Quality Systems.
  • Maintain and enhance cooperation between Business Process Owners, the Digital Industrialization team, IT, and / or Vendors.
  • Facilitate the definition of global communication needs for the owned systems.
  • Establish and develop KPIs and metrics in collaboration with the Quality Dashboarding responsible.
  • Write, review, and / or approve SOPs, Change Control, Complaints, Deviations, Investigations, and / or CAPA related to the computerized system.

Typical Day :

  • Continuous system improvement; main point of contact to ensure business success in using the program.
  • Be the process data owner for Source QMS.
  • Accountable for the inspection and audit readiness of the platform under the scope of the Quality Digital Industrialization team.
  • Monthly meetings with IT.

    • Skills :

  • English is mandatory; French is a plus.
  • 5 or more years of experience in administration or maintenance of electronic Quality Management Systems or comparable electronic tools in the biosciences or pharmaceutical industry.
  • Knowledge of GxP principles of ICH Guidelines and FDA regulations.
  • Good knowledge of validation requirements for computerized systems in the pharmaceutical environment.
  • In-depth knowledge of QMS processes (complaints, deviations, audits, etc.).
  • Project management skills and experience.
  • Basic knowledge of reporting tools (PowerBI, Qlik, etc.).
  • Knowledge of Veeva Source QMS configuration is a plus.

    • A rate as a freelancer is also possible.

    Benefits :

  • Work-life balance
  • Group insurance
  • Reimbursement for km or company car
  • Monthly allowance (80 euros net per month)
  • A 13th month
  • Training to stay at the forefront of innovation

    • Seniority Level : Associate

    Employment Type : Full-time

    Job Function : Quality Assurance

    Industries :

    Pharmaceutical Manufacturing

    J-18808-Ljbffr