Qualified Person

£65,000 - £70,000

We are on the lookout for an experienced Qualified Person to join our clients dynamic team and ensure the highest standards of quality and compliance. This is your chance to make a significant impact in a clinical-stage company dedicated to developing potentially curative treatments for serious diseases.

As our QP, you will be at the forefront of ensuring compliance with the Human Medicines Regulations and Clinical Trial Regulations.

Your responsibilities will include:

• Ensure batches are manufactured and tested according to GMP and in line with applicable CTA/IND and PSF regulations
  
  
• Review completed batch records and finalize batch dispositions
  
  
• Provide QA leadership and technical expertise across all GMP Operations, including Manufacturing, Tech Transfer, Warehouse, Engineering, Quality Control, Supply Chain, and Operations support
  
  
• Identify and escalate quality and compliance risks
  
  
• Act as the Quality liaison for external clients on commercial programs
  
  
• Ensure complaints, deviations, and significant quality incidents are reviewed and resolved promptly
  
  
• Provide quality assurance insights for various projects
  
  
• Stay informed on regulatory changes to facilitate smooth integration into company SOPs
  
  
• Assist in self-inspections by coaching auditors and reviewing audit outcomes.
  
  
• Conduct external audits as needed
  
  
• Create and deliver training related to the QMS and other role-specific topics
  
  
• Ensure all work adheres to GMP, Data Integrity, and Good Documentation Practices (GDP)
  
  
• Ensure timely closure of assigned GMP documentation, including CAPAs, Change Controls, and audit/inspection actions
  
  Your background:
  
  
• Eligibility to act as a Qualified Person as defined in Human Medicines Regulations and Clinical Trial Regulation is essential
  
  
• Strong working knowledge of GMP principles and extensive experience in quality assurance within a GxP environment
  
  
• Excellent communication skills with the ability to build effective relationships with internal and external stakeholders
  
  
• Extensive knowledge of pharmaceutical quality assurance and GMP within an operational environment
  
  
• Proven track record of improving Quality Management Systems
  
  
• Strong understanding of cGMP regulations, including the Orange Guide, Eudralex Volume 4, and U.S. 21CFR parts 210/211
  
  Be part of a groundbreaking organization focused on developing innovative gene therapies for significant unmet medical needs. With a state-of-the-art manufacturing facility designed to meet global regulatory requirements, you’ll play a crucial role in transforming the gene therapy landscape