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Lead Qualified Person

2 months ago

Oxfordshire, United Kingdom AssureBio Full time

AssureBio has an opportunity for a Lead Qualified Person (QP) to join our clients diverse team, supporting the manufacture of innovative medicines in development 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: Certify Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) ensuring compliance with current and emerging regulatory requirements.
  • 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, including leading dialogues with the MHRA and the Innovations Office.


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


**Express your interest if you would like to contribute to the development of innovative medicinal products with a potential world-changing impact.**