R&D Quality Manager

Essential Job Functions
  • To oversee all QA activities from cell banking through to final release to clinical trial sites
  • Liaise with CMC project teams to ensure timely delivery of clinical trial supply materials
  • Provide CMC teams with information and guidance on Quality related issues
  • Prepare, manage and execute QA project plans
  • Prepare, or oversee management of, Product Specification Files
  • Review and approve Quality documentation relating to manufacture, testing and release of materials to be used in pre-clinical or clinical trials where appropriate, including those arising from validation and tech transfer activities
  • Provide quality oversight for complex development supply chains encompassing internal and external suppliers of raw materials, drug substance and drug product manufacture and testing related to clinical trial supplies:
    • Provide Quality input into supply chain activities such as approval of new suppliers, raw materials, components, subcontractors
    • Liaise with third parties over QA related project matters, including preparation of QA agreements. Ensure third party QA related requests are reviewed and incorporated into appropriate documentation where required.
    • Act as person-in-plant for manufacture/testing activities performed at subcontractors, where required.

Skills, Knowledge and Personal Attributes

  • Attention to detail
  • Appreciation of need to comply with regulatory requirements
  • Good organisational skills
  • Excellent communication and interpersonal skills, with the ability to provide support to other teams in meeting the commitment to cGMP and patient safety.
  • Keenness and ability to assimilate information for new Investigational Medicinal Products and apply relevant product quality specifications and in process controls.
  • Some flexibility in working hours.
  • Good knowledge of IT systems.
  • Ability to work to written systems, and a methodical approach to performing duties.
  • Helpful attitude, highly motivated team worker.
  • Required: demonstrable ability to follow written procedures and to evaluate systems and records.
  • Preferred: experience in Pharmaceutical Quality systems.
  • Strong technical expertise in pharmaceutical validation
  • Ability to travel both nationally and internationally up to 20% of working time

Minimum Qualifications:

Relevant experience within a Pharmaceutical R&D or commercial environment with a bachelor’s degree or equivalent in Biology, Chemistry or Health Related Science.

  • Experience in pharmaceutical Quality related role in a relevant pharmaceutical manufacturing environment.
  • Experience in quality systems, quality methods, statistics, product qualification/validation, and a basic understanding of clinical product supply requirement
  • Eligibility to act as a QP / trainee QP would be an advantage.
  • Evidence of a high level of proficiency with IT Systems.

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.