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GCP QA Manager

Employer
i-Pharm Consulting
Location
London, England
Salary
GBP50000.00 - GBP60000 per annum + bonus, pension, healthcare
Start date
29 Nov 2022
Closing date
7 Dec 2022

View more

Discipline
Quality, GCP
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Company

At the forefront of drug evolution, the London-based CRO are leading the way for First-in-Human studies, working with a variety of molecule types varying from small molecules to monoclonal antibodies, RNA therapeutics and most recently gene editing. Taking assets from First-in-Human to Proof of Concept, they are committed to advancing science and driving innovations in drug development using Adaptive Protocols and efficient Patient Recruitment. Expertise to reduce drug development timelines using knowledge and expertise accumulated from over 500 clinical trials.

Working with leading genetic engineering organisations, top 10 pharma companies and dynamic biotechs to assess the safety and efficacy of new therapeutics, they have helped to deliver 30 medicines to market.

As their patient offering expands, so do their facilities, with dedicated patient wards meeting the highest patient safety standards and ensuring participants have a comfortable stay, standing by their MHRA-accredited Phase I unit.

The clinical unit is in the heart of London with easy access to mainline train stations and airports. Committed to clinical excellence for two decades, the vision was to create a new clinical study infrastructure: a unit nested in a hospital setting - allowing clinicians to participate in high-end studies.

Role

As the QA Manager GCP you are an integral part of the quality organisation, handling up to 3 direct reports will require your presence on site, the main duties are outlined below:

  • Managing all QA activities within clinical trials
  • Reviewing SOPs
  • Managing all quality documents and QMS activity
  • Implementing and managing CAPAs
  • Conducting internal and external audits within clinical trials
  • Ensuring full GCP/GMP compliance throughout the Quality department

The ideal candidate will have:

  • Minimum 4 years of GCP QA experience
  • Clinical trials auditing experience is essential
  • QMS software knowledge
  • Knowledge of ICH GCP, and GMP guidelines
  • GCP/GMP compliance knowledge
  • Hosting internal and external quality, regulatory or sponsor audits

If you believe you are the ideal candidate, apply now!

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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