Senior Quality Assurance Manager

My client is an imaging diagnostics company working specifically on the commercialisation and development of PET imaging agents to inform clinical management and guide care for cancer patients. One product is already released and used on a huge global scale, and now  pipe line of two new, cutting-edge products being brought into the market this year! This company’s success is huge and they are now actively expanding their teams, particularly with quality assurance professionals, so this is the perfect time to join and grow with a company!

An organisation that is funded by one the the most influential and premium investors in the world, can add an excellent addition to your CV, whilst also giving you the ideal job satisfaction by having a hands on, positive impact on patients lives!

As a smaller company, the hierarchy is limited, and therefore the opportunity to progress is strong and clear, and you will be working in a supportive, friendly but pro-active environment where autonomy is highly recognised and rewarded!

ROLE

This position can offer a diverse and exciting opportunity to be the key part in a team, establishing a high level of compliance across the company portfolio. GCP audits are a big part of this position, so it is vital you are strongly familiar with this before application.

  • Supporting development and maintenance of the Quality Management System; including preparation and revision of SOP's
  • Maintain the GCP audit schedule and all records
  • Track audit, inspection and self-reported CAPAs 
  • Provide compliance support and guidance as a GCP representative on assigned project teams
  • Conduct training for personnel such as EU, FDA, ICH GCP, SOPs and regulatory requirements for clinical trials etc.
  • Supporting the Head of QA and Chief Medical Officer regarding GCP investigations
  • Supporting head of QA of any quality initiatives

YOU NEED

  • Science degree in relevant discipline
  • At least 5 years clinical development experience - including 3 years pharmaceutical/biotech company
  • 2 years previous GCP QA compliance role
  • Trained GCP Auditor or holder of sufficient knowledge and experience 
  • Knowledge of EU and US FDA Regulatory Standards
  • Proven experience with Regulatory Authority GCP inspection process.
  • Prior training is preferable 

BENEFITS

  • Small company, working directly with the lead directors giving you impact and influence on the business as a whole
  • Pro active, dynamic and forward thinking team
  • Fast moving biotech, lots of opportunity
  • Excellent addition to your CV being a key part in ground breaking innovations + working with Oncology

 

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