QA Lead & Qualified Person (QP)

QA Lead & Qualified Person (QP)

Location: Luton (with regular travel to Nottingham and North London)
Industry: Sterile Pharmaceutical Products
Direct Reports: 4

About the Role:
We are seeking an experienced and dedicated QA Lead & Qualified Person (QP) to join a growing team, overseeing quality assurance activities across multiple sites. This is a pivotal role ensuring compliance with GMP standards in the manufacture of sterile pharmaceutical products. You will be based in Luton, with regular travel to our facilities in Nottingham and North London.

Key Responsibilities:

• Act as a UK Qualified Person in accordance with Directive 2001/83/EC and UK Human Medicines Regulations.
  
  
• Lead and manage a team of 4 QA professionals, providing mentorship and strategic direction.
  
  
• Oversee batch release of sterile pharmaceutical products, ensuring full compliance with regulatory requirements.
  
  
• Develop and maintain robust quality systems and ensure continuous improvement initiatives.
  
  
• Conduct internal audits and support external regulatory inspections.
  
  
• Collaborate cross-functionally with manufacturing, regulatory affairs, and supply chain teams.
  
  
• Drive quality culture across all sites and ensure alignment with corporate standards.
  
  Requirements:
  
  
• Must be a UK-registered Qualified Person.
  
  
• Minimum 5 years’ experience in pharmaceutical quality management, ideally within sterile manufacturing.
  
  
• Strong leadership and team management skills.
  
  
• In-depth knowledge of GMP, MHRA, and EU regulatory requirements.
  
  
• Willingness to travel regularly between Luton, Nottingham, and North London sites.
  
  
• Excellent communication, problem-solving, and decision-making abilities.
  
  What We Offer:
  
  
• Competitive salary and benefits package.
  
  
• Opportunity to lead quality operations across multiple sites.
  
  
• Supportive and collaborative working environment.
  
  
• Career development within a growing pharmaceutical organization.
  
  Key Words:
  
  Quality Assurance, QA, QP, Qualified Person, compliance, operations, operational, Lead, Manager, Head, Senior, Leadership, pharmaceutical, medicine, sterile, aseptic, compounding, biopharmaceutical, audit, auditor, batch release, GMP, cGMP