Senior Quality Specialist

3 semanas atrás

Porto, Portugal AL Solutions Tempo inteiro

George Higginson is currently searching for an experienced Senior Quality Specialist. You MUST have experience with GCP (Good Clinical Practice) across Ph. III. He is partnering with an up-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases.

In this pivotal role, you will support senior management in ensuring Quality is at the heart of all company initiatives and act as advisor to the Clinical Development teams on all quality related GCP activities.

Main Responsibilities:

  • To play a key role in defining, maintaining and monitoring the GxP Quality Management System (QMS)
    • To ensure that their QMS meets all necessary regulatory requirements, including good-practice guidelines and standards, with specific emphasis on GCP compliance.
  • To provide support and advice to Clinical Development teams with regards to:
    • Definition of appropriate compliant procedures within GxP functions
    • Management of quality issues
  • To ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.
  • To monitor the performance of GxP service providers with regards to the relevant quality standards.
    • To define and manage clinical audit programme.
    • To perform GCP audits if required (occasionally on short notice).
  • Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
  • To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.

Requirements:

  • 7-8 years of experience in a similar field.
  • Scientific degree (ideally pharmaceutical science, Biology, chemistry or related).
  • GCP experience in Ph. III interventional studies is a requirement.
  • Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment.
  • Prior experience interacting with clinical sites in a CRO or through a Pharma and/or Biotech.
  • Ability to travel on-site to their Porto office, x2 days p/w.

How

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