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Lead Qualified Person

2 months ago

Oxford, Oxfordshire, United Kingdom AssureBio Full time
Job Title: Lead Qualified Person

AssureBio is seeking a highly skilled Lead Qualified Person to support the manufacture of innovative medicines in development. This is a fantastic opportunity for a Qualified Person who is interested in developing medicinal products and becoming involved in GMP manufacturing expansion.

Key Responsibilities:

  • Certification: Ensure compliance with current and emerging regulatory requirements for Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs).
  • Import Declarations: Complete QP declarations for imported products from India, the USA, and other countries.
  • Portfolio Management: Manage QP activities including partial batch manufacture, clinical trial labelling, and final certification.
  • Quality Assurance: Collaborate with the Head of Quality to maintain an effective Quality Management System in compliance with EudraLex Volume IV.
  • Senior Management: Communicate quality and regulatory updates to the Senior Management team.
  • Training and Audits: Lead training sessions, self-inspections, external audits, risk assessments, change controls, CAPAs, and investigations including deviations, out of specifications, complaints, and product recalls.
  • Contract Management: Oversee work conducted by contract QPs and ensure the effectiveness of the Quality Management System.
  • GMP Expertise: Provide GMP expertise for major capital projects related to facility and equipment.
  • Regulatory Advice: Advise internal and external staff on legislation and guidance for novel manufacturing processes and QC testing strategies.

Essential Qualifications and Experience:

  • Degree in Chemistry, Biology, or Pharmacy.
  • Member or higher position in the Royal Pharmaceutical Society, the Royal Society of Biology, or the Royal Society of Chemistry.
  • Experience in the manufacture of biological and sterile medicinal products.
  • Competence in managing all aspects of Quality Assurance in a GMP regulated environment.
  • Strong knowledge of EU GMP guidelines (EudraLex Volume 4) and ability to interpret these for early-phase IMPs and ATMPs.
  • Pharmaceutical Auditor experience.
  • Managerial or supervisory experience with proven leadership skills.
  • Significant scientific and technical expertise in a GxP environment, along with extensive experience in a manufacturing or Quality role.

Desirable Experience:

  • Extensive experience in biopharmaceutical, ATMP, or vaccine manufacturing.
  • Broad understanding of current and novel technical and scientific processes, including various bioprocessing methodologies and analytical techniques.
  • Experience hosting regulatory inspections and external audits.
  • Experience importing IMPs and ATMPs from the EU and third countries.

Benefits:

  • Competitive Salary
  • Excellent contributory pension scheme
  • 38 days annual leave
  • Comprehensive childcare services
  • Family leave schemes
  • Cycle loan scheme
  • Discounted bus travel and Season Ticket travel loans
  • Membership to a variety of social and sports clubs
  • A welcoming and diverse community

**Contribute to the development of innovative medicinal products with a potential world-changing impact.**