Head of Quality/QP

3 weeks ago

Glasgow, United Kingdom BDD Full time

Job Summary 

Due to continual expansion and demand, an exciting opportunity has arisen within BDD Pharma for a Head of Quality/QP to join our team. In this role you will be responsible for the QP release and certification of IMPs, overseeing BDD’s Quality Management System and promoting a continuous quality improvement culture across the business.  

 

Our clients come to us for help with challenging projects to treat real medical needs across a range of therapeutic areas which brings variety and interest to our roles. The ideal candidate will have a strong background in Quality Assurance and Pharmaceutical Manufacturing, experience with releasing IMPs would be advantageous. We are looking for a confident individual who shares our enthusiasm for delivering on customer excellence and our passion for science. In return you will join a fast-paced, start-up like environment where initiative and a questioning mind is valued.  

 

Key responsibilities are as follows: 

 

  • QP release and certification of IMPs and comparators for use in clinical trials ensuring compliance with ICH, GMP and local regulations 
  • Reviewing and approving Batch Manufacturing Records, analytical data and other documentation relating to IMP manufacture and QC testing. 
  • Maintain Quality Management System to ensure compliance with regulatory guidance and industry best practice 
  • Assessing planned changes, OOS / OOT, unplanned deviations, CAPA and CAPA effectiveness. 
  • Supplier Management including maintenance of approved vendor system and performance of external audits covering API's, CMO's, Contract Laboratories, Excipients, Packaging and other GDP / GMP contractors, as required. 
  • Provide technical and scientific advice on development programmes for Phase I-II IMPs to operational teams 
  • Management of Quality Assurance team 
  • Hosting customer, third party and regulatory audits 
  • Maintaining a continuous improvement system that will allow the consistent delivery of BDD services with appropriate quality attributes 


Education, Qualifications and Experience 

 

Essential 

  • Eligible to act as a Qualified Person under the permanent provisions of EU GMP 
  • 5+ years of professional experience in Quality Assurance within the pharmaceutical industry 
  • Demonstrable detailed knowledge of UK and EU GMP regulatory requirements 
  • Excellent team player with track record of building and sustaining positive relationships with colleagues and clients 
  • Meticulous attention to detail in recording data and ability to act on queries in a timely and efficient manner. 
  • Full UK driving licence (this role will require travel between BDD’s two sites) 
  • Previous experience of leading MHRA Inspections 


Desirable 

  • Minimum of 2 years QP experience post qualification 
  • 2+ years of experience with oral solid dose and IMP manufacturing 
  • Experience of releasing radiopharmaceuticals  
  • Working knowledge of QPulse QMS 
  • Knowledge of UK and EU GCP regulatory requirements and the MHRA Phase I accreditation scheme 

 

Company Overview 


BDD Pharma is rapidly growing research focused drug delivery company based in Glasgow with clinical trial, formulation development and GMP manufacturing capabilities. We specialise in the development of novel pharmaceutical products and undertaking bespoke clinical services which help our customers better understand how their drug delivery systems perform. When you join BDD, you become part of a team dedicated to supporting the development of new medicines and improving the health of others. 

 

Why join BDD? 

  • We offer a competitive salary and benefits package which includes private healthcare through Vitality, a generous pension scheme and access to our employee assistance programme with Health Assured. 
  • You will receive 35 days annual leave inclusive of bank holidays 
  • You will be part of a young workforce with an open and transparent culture which is maintained throughout the business. 
  • The opportunity to work on a variety of projects across a range of therapeutic areas, helping to shape the development of new medicines with some of the world’s biggest pharmaceutical companies and those at the forefront of technological advances. 
  • We offer a unique working environment with integrated formulation development, GMP manufacturing and clinical research services. This means that every day is different. Working at the cutting edge of early-stage drug development and clinical research provides a challenging environment with continued learning. 

 

If you are interested in joining the BDD team please e-mail your CV and a covering letter, outlining your experience and suitability for the position to: careers@bddpharma.com 

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