Senior Quality Manager

4 weeks ago

Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full time

Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.


Key Responsibilities:


  • To play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with 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 and to preform GCP audits if required.
  • 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.


Skills/Knowledge Competencies:


  • 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
  • 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.


Experience:

  • Minimum 5+ years in a similar role


Salary and benefits:


A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.

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