Qualified Person

Summary of the role

The role of a Qualified Person (QP) is one of the most senior and legally responsible positions in the pharmaceutical and life sciences industries. It’s a career path that requires extensive experience and a specialised set of qualifications, and it comes with a high degree of authority and trust.

A Qualified Person is a key figure in quality assurance who holds a legal and professional responsibility to certify that every batch of a medicinal product has been manufactured and tested in compliance with its Marketing Authorisation or Clinical Trial Application, and, most importantly, with the principles of Good Manufacturing Practice (GMP). They are the final gatekeeper before a medicine can be released to the market or used in a clinical trial. In advanced therapies, where batches may be personalised and highly sensitive, the QP’s role is even more critical and resource intensive.

Typical Duties

The duties of a QP are primarily focused on oversight, compliance, and decision-making:

• Batch Release Certification: This is the core legal duty. The QP must personally sign off on the batch record for every batch of medicinal product, confirming that it has been manufactured, packaged, and tested according to all regulatory requirements.
• Review of Deviations and Investigations: A significant part of the role is to review and approve all deviations from the standard manufacturing process. The QP must assess the impact of any deviation on the quality of the product and decide whether the batch is still safe to release.
• Quality Management System Oversight: The QP is responsible for ensuring that the entire Quality Management System (QMS) is robust and effective. This includes reviewing and approving SOPs, change controls, and corrective and preventive actions (CAPAs).
• Auditing and Vendor Assurance: The QP may be involved in auditing suppliers and contract manufacturing organisations to ensure they meet GMP standards. This is crucial for managing the complex global supply chain.
• Regulatory Interactions: The QP is a key point of contact for regulatory bodies like the Medicines and Healthcare products Regulatory Agency (MHRA) during inspections and audits.

While the legal responsibility is the same for both advanced therapies and broader life sciences, the application of the QP role is different:

Advanced Therapies: The QP’s role in advanced therapies manufacturing is particularly challenging. Batches are often for a single patient, and the QP must perform a detailed review of each one, sometimes with a very tight timeframe. The assessment of deviations is extremely complex due to the personalised and highly sensitive nature of the product.

Wider Life Sciences: In traditional biopharma, a single batch may be used to treat thousands of patients. The QP’s decisions are still of immense importance, but the scale and nature of the manufacturing process are different.

Key Skills and Qualifications (UK)

Essential Qualifications: You must have a degree in a relevant scientific discipline such as Pharmacy, Chemistry, Biochemistry, or a related field. After your degree, you need to complete a comprehensive and accredited training program covering a defined “body of knowledge” set out in the UK QP Study Guide. This typically takes several years.

Essential Certifications: The title “Qualified Person” is a legally protected and regulated status in the UK. You must be nominated by a professional body (e.g. Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society) and approved by the MHRA to be included on the official register. This process includes extensive training and a final oral examination (viva).

Essential Skills:

• Thorough Knowledge of GMP and Regulatory Law: This is non-negotiable. The QP must have an in-depth understanding of the laws and regulations governing medicinal products.
• Exceptional Judgment: The ability to make confident, well-reasoned decisions under pressure is paramount.
• Leadership and Communication: The QP must be able to lead investigations, communicate complex technical and regulatory issues to both technical and non-technical audiences, and be a voice for quality within the organisation.
• Attention to Detail: A meticulous approach is vital, as the QP’s signature is a legal declaration of a product’s quality.

Salary Expectations (UK)

Starting Salary: For a newly qualified QP, a starting salary is typically in the range of £55,000 – £70,000 per year.

After 3-4 Years: With a few years of post-qualification experience, a QP can expect a significant increase in salary, often reaching £75,000 – £95,000 or more, depending on the size and location of the company and the level of responsibility.