Qualified Person
A Qualified Person (QP) operates within the quality assurance function of a pharmaceutical company and has a crucially important role because he or she takes legal responsibility for certifying that batches of medicines are safe prior to release. This “batch release” refers to the release of medicines to be used in either clinical trials or for sale in the commercial market.
Qualified Persons must be nominated by certain regulatory bodies, one of which is the Royal Pharmaceutical Society, to certify that they are eligible for the role. In the UK and most of Europe, nominations for QP status are subsequently approved by the Medicines and Healthcare products Regulatory Agency (MHRA), which has the final say as to who can be named a Qualified Person within pharmaceutical manufacture. In order to be nominated as a QP, applicants must have an in depth understanding of the pharmaceutical industry, combined with extensive training that covers a number of different modules.
In a recent blog (bit.ly/2syLrq) Next Phase Recruitment Specialist Julie Nicholls explains that new EU Regulations coming into force soon will mean that medical device companies will now also need to appoint a Qualified Person. This will have significant implications for the UK market, where QPs are already in short supply. An experienced Qualified Person will often prefer to work on a consultancy basis, for the variety of work, significant daily pay rates, and ability to work with a number of different clients at the same time.
Skills and Experience required to become a QP
Typically a QP will need the following skills and experience:-
- Degree level education in a scientific discipline such as pharmacy, chemistry, biomedical science
- Nomination as a QP by a relevant regulatory body plus MHRA approval
- Detailed understanding of pharmaceutical law, quality management systems and the professional duties of a QP
- Substantial experience within the pharmaceutical industry
- Statistical and mathematical skills
- In-depth understanding of the manufacture and supply chain
- Leadership skills
Salary Level
Pay rates for QPs vary enormously depending on where they are based and their main areas of specialisation (e.g. IMP / commercial). A recently-registered Qualified Person may command a salary of £55k - £70k initially, but this can increase quickly to £75k - £95k once the QP has some post-qualification experience. Similarly, QP contract rates can vary a great deal. QP pay rates can be anything from £650 / day to £1,100 / day depending on the length and complexity of the contract, and this may also vary depending on what additional skills the QP can provide (such as a background in Pharmacy, for example).
Scotland
Scotland is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain.
The global cell and gene therapy market was valued at $6.68 billion in 2019 and is expected to reach $13.23 billion in 2023 at a CAGR of 24.10% (Ref. BusinessWire).Also in 2019, a joint report from The Alliance for Regenerative Medicine (ARM) and the BioIndustry Association (BIA) stated that the UK is a leading source of innovation and development of advanced therapy medicinal products (ATMPs) in Europe. These products, which include gene therapies, cell therapies, and tissue-engineered products, are intended to augment, repair, replace, or regenerate organs, tissues, cells, genes, and metabolic processes within the body. Scotland has a strong reputation in research & translational development in these fields and is rapidly growing a vibrant cluster of spin-out therapeutic companies, increasing clinical trials of new Advanced Therapy Medicinal Products (ATMPs) as well as expanding its manufacturing capability.
Scotland also has established expertise in developing and manufacturinghuman vaccines(the global market projected to grow to $96b by 2023 according to Business Research Company) and animal vaccines (worth $9b by 2025 – Global Market Insights, Inc).
Scotland’s profile and contribution towards the growth of the UK ATMP sector is increasing rapidly. A strengthening supply chain is supporting new advanced therapy applications – fuelled by world-leading academic expertise in cell & gene therapy and regenerative medicine,. With a forward focus on translation, specialised clinical trials, and GMP manufacture and analysis, Scotland is growing a vibrant infrastructure to support end-to-end development of advanced therapies.
Human and animal vaccine development is a strength in Scotland represented by companies such as Valneva, Neogen, and GalvMed as well as the Moredun Research Institute. In addition to Valneva’s Covid-19 Vaccine programme, Scotland’s supply chain made huge contributions to the development of Covid-19 vaccines including Merck BioReliance, Charles River, Symbiosis, SGS, Ingenza & ReproCell Europe.
One of the largest life sciences clusters in Europe, Scotland is home to a range of multinationals and small and medium enterprises (SMEs) with a strong track record of creating and growing startups.
Scotland has comprehensive supply chains and world class manufacturing expertise supplying chemical and healthcare equipment, pharmaceutical services, medicines, vaccines and diagnostics to the world.
The cluster continues its rapid expansion building on a strong industry base, leading universities with a thriving entrepreneurial culture and close collaborations across industry, academia, the National Health Service and government.
Scotland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Scotland, scientific careers in Scotland or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Scotland, give our Next Phase team a call. The Scottish area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in Scotland, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the Scottish area.
