Clinical QA Manager

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
London, England
Posting date: 26 Oct 2023

Proclinical are recruiting for a Clinical QA Manager to join a biotech organisation. This role is on a permanent basis and is located in London.


  • Assist the clinical operation team with preparing, arranging and managing regulatory agency inspections.
  • Evaluate and update the company's SOPs, recognising the requirement for new SOPs as well as evolve new quality SOPs.
  • You will develop and measure GCP quality metrics to drive constant quality standards throughout the business.
  • Possible serve as a clinical development quality lead for a specific project or as back-up if necessary.
  • Train and business shareholders by offering guidance, knowledgeable advice, assistance and management for translating the quality method into operations.
  • Partake in ideal CRO/Vendor selection and qualification procedure, examine pertinent CROs process throughout selection procedure.
  • Uphold databases for investigator site audit observations and CAPAs.
  • The ideal candidate will track, evaluate, approve and examine the sufficiency of CAPAs.
  • Work alongside the compliance QA team on tracking vendor audits and CAPA tracking for external clinical vendors.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Demonstrable experience with clinical quality assurance with familiarity in clinical auditing/oversight in the regulatory compliance setting or a corresponding mixture of experience and education.
  • Follows ethical and GCP with the ability to work well in a team as well as independently.
  • Competency in ICH GCP, FDA and suitable CFRs guidance documents, systems procedures and processes which involves working within a QA role assisting on regulations compliance.
  • Comprehension of suitable US and ICH GCP guidelines/regulations to enable the comprehension and impact of discoveries of both internal and external audits.
  • Stay updated on changes to current GCP/GLP/GCLP guidelines, regulations, safety reporting which involves FDA, EU, and any other regulatory bodies.
  • Familiarity within clinical operations and managing necessary documents.
  • Prior involvement in performing PV, GLP and/or GMP audits would be beneficial.
  • Interpersonal, deliberation and communication skills both verbally and in writing.
  • Able to resolve issues.
  • Capable of upholding company ethical standards.
  • An organised individual with the ability to work on various projects simultaneously with competitive timelines.
  • Capable of handling multifaceted projects.
  • Willing to travel for business needs which might involve global travel.
  • Computer literacy.
  • A high attention to detail.
  • Works well in a team.

If you are having difficulty in applying or if you have any questions, please contact Ieuan Phillips at +44 203 846 0643.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.