Head of Quality of Biologicals
| Posting date: | 03 September 2024 |
|---|---|
| Salary: | £67,640 to £75,965 per year |
| Hours: | Full time |
| Closing date: | 30 September 2024 |
| Location: | KT15 3LS |
| Company: | Government Recruitment Service |
| Job type: | Permanent |
| Job reference: | 361967/1 |
Summary
This exciting and interesting job puts you at the heart of animal health and welfare in authorising biological/immunological veterinary medicinal products (VMPs) including vaccines in the UK. Your work will play a major role in assuring the quality, safety and efficacy of these medicines and will significantly contribute to VMD’s objective of ensuring the availability of appropriate and innovative biological/immunological VMPs including vaccines to protect animal health and welfare.
You will be responsible for leading the assessment of the quality requirements of applications for marketing authorisations for biological/immunological VMPs which are authorised for use in the UK.
The role of the Head of Quality of Biologicals is to lead and manage the assessors involved in the assessment of the quality aspects of biological VMPs as well as associated work processes, to carry out assessments of certain applications as well as to peer review those carried out by other members of the team. You will be responsible for the continued development and training of assessors in these areas. You will lead on formulation of national and international regulatory policies and guidelines for VMPs including novel therapy VMPs and on the provision of scientific and regulatory advice to applicants and stakeholders. You will lead on VMD’s global cooperation initiatives in regulatory affairs, work-sharing across regulatory jurisdictions, and capacity strengthening. You will report to the Head of the Biologicals Section and deputise for them.
Whilst this role within the Biologicals Section has a focus on quality it is expected due to the nature of biological/immunological VMPs that the job holder will be sufficiently experienced to be able to understand the key aspects of quality, safety and efficacy requirements of these VMPs in particular interdependent key attributes that contribute to/ensure the overall quality, safety, efficacy and benefit/risk balance of the product.
The VMD is committed to supporting innovation of biological/immunological VMPs including novel therapies VMPs. The post holder will provide expert input into the assessment of quality aspects medicines submitted for authorisations of novel therapies VMPs, scientific advice and development of guidance/regulation for these medicines.
The key responsibilities of the role are:
Leadership:
- Lead, manage and supervise the team of assessors involved in the assessment of quality and overall benefit risk of biological VMPs.
- Work with the Head of Biologicals to coordinate the allocation of work and resources to ensure business targets are met efficiently.
- Contribute to the formulation of national and international regulatory policies and guidelines for biological/immunological VMPs including novel therapy VMPs.
- Support the implementation of the Veterinary Medicines Regulations (2013, as amended) and delivery of VMD’s Regulatory Science Strategy (2021-2026).
- As part of the senior leadership team, to contribute to the wider corporate aims and objectives of the VMD including support to the international agenda.
Quality of science:
- Assess certain applications and prepare written assessment reports for marketing authorisations for biological/immunological VMPs and clinical field trials in compliance with legislation, guidance and standards. This will include applications for complex and novel therapies VMPs.
- Present these reports to VMD’s formal committee charged with recommending approval or rejection of applications.
- Peer review assessments and assessment reports prepared by the team to ensure the scientific and regulatory quality of the applications progressed by the assessors involved in the quality assessment, including compliance with legislation, guidance and standards.
- Assess data for autogenous vaccine authorisations (AVA) and liaise with Inspectors appropriately on the manufacturing and inspection aspects.
- Provide expert scientific, technical and regulatory support to assessors.
- Develop and update assessment procedures and guidelines.
External engagement:
- Provide and coordinate team scientific and regulatory advice and guidance to applicants and stakeholders.
- Represent the organisation at national and international strategic meetings, committees and conferences.
- Liaise with National and EU industry representative bodies.
- Monitor emerging diseases and any change in the global animal health situation and assess and report on the implications of such changes to the regulatory environment, setting appropriate strategic direction.
- Support VMD’s initiatives for global cooperation, work-sharing across regulatory jurisdictions, and capacity strengthening.
Internal engagement:
- Work collaboratively with other VMD teams for effective regulatory oversight specifically the Pharmaceuticals, Pharmacovigilance, Inspection and Legislation Teams.
- Provide and coordinate team expertise and support to VMD colleagues on quality issues, including policy development, batch release, product defects and import certificates.
Developing the Team:
- Cultivate leadership skills, specialisms and awareness of scientific and regulatory developments within the team.
- Plan for and identify assessor’s future skills and training needs, including novel therapies and technologies.
- Provide training and mentoring to enhance team capabilities.