Director, Quality Assurance

4 weeks ago


Cambridge, United Kingdom AL Solutions Full time

Job Description:

George Higginson is currently searching for an experienced Director of Quality Assurance in GCP. He is partnering with an up-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases.

In this position, 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 the 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 (for example audits to be conducted at 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:

  • 8+ years of experience in a similar role.
  • Scientific degree (ideally pharmaceutical science, Biology, chemistry or related).
  • GCP experience in Ph. III interventional studies is a requirement - strong Ph. II can be considered as an alternative.

How


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    George Higginson is currently searching for an experienced Director of Quality Assurance in GCP. In this position, 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. To play a key role in defining, maintaining and...

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