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Head of Quality and Software Validation

Head of Quality and Software Validation

Software Development, Software Validation, Annex 11, GCP, FDA, ISO standards, GAMP (Software as a Medical Device), Auditing, Agile, Assurance QA, Pharmaceutical / Medical / Biotech / Healthcare Industry

  • £75,000 - £85,000 Per Annum
  • Hybrid working - London Head Office
  • Annual Bonus
  • Excellent Benefits

The Role

The Head of Quality and Software Validation will support the design /development /testing /verification /validation and full life cycle management of software developed internally or purchased by the business. You will own the draft, review, and approval process of software development and validation policies whilst setting best practise and ensuring compliance with FDA 21 CFR Part 11, GCP, EU Annex 11, GAMP, pertinent ISO standards and regulatory and quality management system requirements.

Our long standing client are exclusively partnered with us to secure a Head of Quality and Software Validation to act as an SME for all software validation and verification processes.

The Head of Quality and Software Validation will be working within the Biomedical/Biotech industry so experience working within Pharmaceutical, Health, Biotech, Biomedical or Medical industries is essential! As is a courageous and confident attitude in order to work with external customers on internal audits and to prevent premature releases internally until validation is complete.

Role Requirements for the Head of Quality and Software Validation:

Essential:

  • Software Development and Validation experience
  • Pharmaceutical / Medical / Healthcare / Biomedical / Biotech industry experience
  • Agile / GAMP / Annex 11
  • Analytical Skills
  • Internal auditing experience
  • Degree level lor above

Beneficial:

  • Cloud based systems knowledge
  • GDPR/HIPPA
  • AI / Machine learning
  • IOS experience
  • SaMD (Software as medical device)
  • Clinical trials and medical imaging experience - MRI

The company

This is the chance to make an impact with your work. At this company you will be part of the battle to help cure and manage some of the world's most detrimental diseases such as Alzheimer's, Parkinson's and Huntington's disease. They use artificial intelligence to gather data analytics and help their clients reduce clinical development risk.

This is a company that cares about the world as much as they care about the people that work for them, they offer an extensive list of benefits and bonuses as well as having an incredible work environment where everyone is pushed to be the best version of themselves!

This is a crucial role for the business and you will be a subject matter expert for all software verification and validation, reviewing and approving suitable software development and verification documentation and more.

For more information please apply ASAP.

  • £75,000 - £85,000 Per Annum
  • Hybrid working - London Head Office
  • Annual Bonus
  • Excellent Bonuses

Software Development, Software Validation, Annex 11, GCP, FDA, ISO standards, GAMP (Software as a Medical Device), Auditing, Agile, Assurance QA, Pharmaceutical / Medical / Biotech / Healthcare Industry

Head of Quality and Software Validation

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