Senior Quality Assurance Specialist

4 weeks ago

Cambridge, United Kingdom AL Solutions Full time

George Higginson is currently searching for a highly experienced Senior Quality Assurance Specialist for a clinical-stage Biotech, specialising in Immunology space. They currently have x2 compounds in Phase 3 clinical trials.

In this pivotal role, as the Senior Quality Assurance Specialist, you will support senior management in ensuring Quality is at the heart of all company initiatives and, specifically, will 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:

  • Scientific degree (ideally pharmaceutical science, Biology, chemistry or related).
  • Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment.
  • Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies.
  • Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience.
  • Comprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.
  • Basic understanding of GLP and GMP requirements for biologics.
  • Strong communication, negotiation and influencing skills.
  • Strong conflict resolution abilities.
  • Basic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.
  • Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.
  • Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
  • Ability to find pragmatic solutions for quality issues in a highly agile biotech environment.
  • Be able to travel x2 days p/w to their site in Cambridge, UK.

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