Quality Assessor - 60,778 - 68,422 p.a. + benefits

We are currently looking for a Quality Assessor to join our Innovative Medicines Team Function within the Health Quality and Access group.

This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

Who are we?

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The objective of the Healthcare Quality and Access (HQA) portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards

The Innovative Medicines Unlicensed Medicine function, part of HQA, delivers a risk-based appraisal of Unlicensed medicines and whether they may or may not be supplied within the UK, to safeguard public health. It enables wider access to these important medicines when licensed medicines are not available to meet the needs of individual patients.

Whats the role?

Quality Assessors form part of multidisciplinary teams and will specifically assess the quality aspects of initial applications for the marketing authorisation (MA) of biological medicinal products and subsequent variations to existing MAs.

They are responsible for providing scientific and regulatory advice to internal and external stakeholders, supporting UK healthcare innovation of biological medicinal products. Assessors will also be expected to participate in non-assessment activities such as maintaining and developing regulatory and scientific guidance and engaging with stakeholders to deliver wider agency goals.

Key responsibilities:

• Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
• Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
• Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
• Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.

Who are we looking for?

Our successful candidate will demonstrate the following:

• Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred.
• In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).
• Up to date, detailed, specialist level of knowledge in one or more relevant scientific areas and broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of biological medicinal products.
• Experience communicating technical information accurately and effectively to relevant parties evidencing excellent written and verbal communication skills.
• Working Together

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Behaviour Criteria:

• Making Effective Decisions (A,I)
• Working Together (A,I)
• Managing a quality Service (A,I)

Experience Criteria:

• Ability to handle throughput of work commensurate with experience and knowledge to meet required deadlines. (A,I)
• In depth experience in: regulatory affairs, research and development, manufacture or quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent). (A,I)
• Demonstrable experience of developing successful relationships with both internal and external stakeholders, with excellent communication skills. (A,I)
• Experience communicating technical information accurately and effectively to relevant parties evidencing excellent written and verbal communication skills. (A,I)

Technical Criteria:

• Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred. (A)
• Up to date, detailed, specialist level of knowledge in one or more relevant scientific areas and broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of biological medicinal products. (A,I,T)
• Keen attention to detail, a proven ability to apply critical thinking to complex problems. (A,I,T)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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