Lead Qualified Person

3 weeks ago

Oxford, Oxfordshire, United Kingdom AssureBio Full time
About the Role

AssureBio is seeking a highly experienced and skilled Lead Qualified Person to join our 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 and Compliance: Ensure compliance with current and emerging regulatory requirements for Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs).
  • Import Declarations: Complete Qualified Person declarations for imported products from India, the USA, and other countries.
  • Portfolio Management: Manage Qualified Person activities including partial batch manufacture, clinical trial labeling, 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 Qualified Persons 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 regulatory authorities.
Essential Qualifications and Experience
  • Education: Degree in Chemistry, Biology, or Pharmacy.
  • Professional Membership: Member or higher position in the Royal Pharmaceutical Society, the Royal Society of Biology, or the Royal Society of Chemistry.
  • Manufacturing Experience: Experience in the manufacture of biological and sterile medicinal products.
  • Quality Assurance: Competence in managing all aspects of Quality Assurance in a GMP regulated environment.
  • Regulatory Knowledge: Strong knowledge of EU GMP guidelines (EudraLex Volume 4) and ability to interpret these for early-phase IMPs and ATMPs.
  • Pharmaceutical Auditor Experience: Pharmaceutical Auditor experience.
  • Leadership Experience: Managerial or supervisory experience with proven leadership skills.
  • Scientific Expertise: Significant scientific and technical expertise in a GxP environment, along with extensive experience in a manufacturing or Quality role.
Desirable Experience
  • Biopharmaceutical Experience: Extensive experience in biopharmaceutical, ATMP, or vaccine manufacturing.
  • Technical Knowledge: Broad understanding of current and novel technical and scientific processes, including various bioprocessing methodologies and analytical techniques.
  • Regulatory Inspections: Experience hosting regulatory inspections and external audits.
  • Import Experience: Experience importing IMPs and ATMPs from the EU and third countries.
What We Offer
  • 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

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