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Lead Qualified Person

2 months ago

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Job Summary

AssureBio is seeking a highly experienced and skilled Lead Qualified Person to join our team and support the manufacture of innovative medicinal products. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our products, from certification to final certification.

Key Responsibilities:

  • Certification and Compliance: Ensure that all Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) meet current and emerging regulatory requirements.
  • 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:

  • 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.