Recruiting QA and Qualified Persons (QP)

Quality roles in pharmaceutical and biotech companies are not support functions. They are a precondition for the product leaving the plant. A vacant QA position can slow down deviation handling and change control, and without a Qualified Person batches cannot be released. At the same time, experienced QA leads and QPs are among the most sought-after profiles in the industry.

Here we explain the difference between the roles, which formal requirements apply, and how to assess candidates for quality roles in a GMP environment.

QA, QC and QP – what is the difference?

Quality Assurance (QA) owns the quality system: deviations, CAPA, change control, validation, supplier qualification, internal audits and inspections.
Quality Control (QC) carries out analysis and testing of raw materials, intermediates and finished products, and is responsible for laboratory operations and method validation.
Qualified Person (QP) certifies that each batch has been manufactured and checked in accordance with GMP and the marketing authorisation before it is released.

In small companies one person may cover several of these roles. In larger organisations they are clearly separated.

Qualified Person: formal requirements

Under EU rules, every holder of a manufacturing authorisation for medicinal products must have at least one Qualified Person. The requirements for the QP follow from the medicinal products directive (Directive 2001/83/EC) and include relevant higher education and at least two years of practical experience in companies holding a manufacturing authorisation. In Norway, manufacturing authorisations are issued by the Norwegian Medical Products Agency (NOMA, in Norwegian DMP).

Two practical tips:

Check the formal requirements early. The authorities assess whether education and experience are sufficient. Clarify this before you are far into the process.
Think about a deputy. What happens during holidays, sickness or a resignation? Many companies need more than one QP, or a plan to develop an internal candidate.

The same applies to companies that manufacture or import medicinal products for clinical trials: here too, a QP must certify the batches.

The experience that really matters

QA CVs can look alike on paper, while the experience behind them is very different. Ask concretely about:

Product type and process. Sterile manufacturing, biologics, advanced therapies (ATMPs), oral solid dosage forms or API? Context matters a great deal.
Inspections. Has the candidate prepared for, taken part in or led inspections? How were the findings handled?
Deviations and CAPA. Can they describe a concrete deviation, how the root cause was found, and how the actions were followed up?
Change control and validation. Which systems and processes have they validated?
Data integrity. How have they applied ALCOA+ principles in practice?
Quality system. For medtech, ISO 13485 and the MDR/IVDR are relevant. Read more in our article on medtech recruitment.

The qualities that set the best apart

Quality roles require technical depth, but also integrity and the ability to get things done. The best candidates:

say no when the documentation does not hold up – even when time is short and production is waiting
explain requirements in a way production and management understand, instead of hiding behind procedures
see the quality system as a tool for operations, not just as control
take responsibility for follow-up, not just for logging deviations

These qualities are best revealed through behavioural questions and concrete cases, not general questions about strengths and weaknesses.

How to assess candidates

Use a case. Give the candidate a realistic deviation scenario and ask them to walk through the assessment: What is the risk, who needs to be involved, and can the batch be released?
Ask about inspections. What was the hardest finding, and what was done differently afterwards?
Take references from QA leaders. Ask about the candidate's judgement under pressure, not just their work ethic.
Involve production. A QA person who does not work well with production becomes a bottleneck.

When it is urgent

If you are left without QA capacity or a QP, a contracted consultant can be a temporary solution. Check with the competent authority what is acceptable for your authorisation, and use the time to recruit a permanent solution. A succession plan makes the company less vulnerable next time.

How Oslo Life Sciences can help

Oslo Life Sciences recruits for quality and technical compliance: QA/QP, Quality Engineers, validation engineers, supplier quality, CAPA and deviation management. We understand the difference between quality work in sterile manufacturing, biotech and medtech, and assess candidates' experience in practice. We search in Norway, the Nordics and DACH, and one adviser follows the assignment throughout.

Building a new company? Read about the first hires in a biotech company, where quality often comes in earlier than many expect.

Frequently asked questions

How much experience does a Qualified Person need?

Under EU rules, at least two years of practical experience in companies holding a manufacturing authorisation is required, in addition to relevant education. Always check the current requirements with the competent authority.

Can a QP be contracted?

Contracted QPs are used in some cases, particularly as a temporary solution. Whether this is acceptable for your company should be clarified with the competent authority.

What is the difference between QA and Regulatory Affairs?

QA ensures that the product is made and handled in line with quality requirements. Regulatory Affairs ensures that the product has the necessary approvals. Read more about Regulatory Affairs recruitment.

What is a PRRC?

PRRC stands for "person responsible for regulatory compliance", a role that manufacturers of medical devices and in vitro diagnostics must have under the MDR and IVDR. The role has similarities with the QP in the pharmaceutical industry.