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Lead Qualified Person

2 months ago

Oxford, Oxfordshire, United Kingdom AssureBio Full time

**Job Summary**

AssureBio is seeking a highly experienced and skilled Lead Qualified Person to join our team, supporting the development and manufacture of innovative medicinal products with the potential to have a world-changing impact.

This is a fantastic opportunity for a Qualified Person who is interested in developing innovative medicinal products and becoming involved in GMP manufacturing expansion to meet the growing demand for life-saving research.

Key Responsibilities:

  • Certification and Compliance: Ensure compliance with current and emerging regulatory requirements for Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs).
  • Import and Export Management: Manage the import and export of medicinal products from various countries, including India, the USA, and other countries.
  • Portfolio Management and Quality Assurance: Manage QP activities, including partial batch manufacture, clinical trial labelling, and final certification, while maintaining an effective Quality Management System in compliance with EudraLex Volume IV.
  • Senior Management and Communication: Communicate quality and regulatory updates to the Senior Management team and provide GMP expertise for major capital projects related to facility and equipment.
  • Regulatory Advice and Training: Advise internal and external staff on legislation and guidance for novel manufacturing processes and QC testing strategies, including leading dialogues with regulatory authorities.
  • Contract Management and Audits: Oversee work conducted by contract QPs and ensure the effectiveness of the Quality Management System, including leading training sessions, self-inspections, external audits, risk assessments, change controls, CAPAs, and investigations.

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