Quality Assurance Talent Monitor Q2 2025…by Barden

The “Quality Assurance Talent Monitor Q2 2025” provides an in-depth analysis of the Quality Assurance (QA) profession within Ireland’s pharmaceutical industry. As a key function ensuring compliance, product integrity, and regulatory adherence, Quality Assurance plays a vital role in maintaining Ireland’s reputation as a leading pharmaceutical exporter.

#1 Continuum of Activity

The below imagery, from left to right, depicts the continuum of activity within the Quality Assurance profession, beginning with Raw Material sourcing and control to QP Batch release.

In Quality Assurance (QA), all activities generally fall within the above 3 key areas, which ensure compliance, effectiveness, and continuous improvement. Here are the 3 main areas:

1.1 Quality Management Systems (QMS)

• Manages document control systems, change control, deviations, and CAPAs (Corrective and Preventive Actions).
• Ensures records are maintained per regulatory expectations.
• Implementation of Good Manufacturing Practice (GMP) requirements per EU GMP guidelines (EudraLex Volume 4).
• Compliance with HPRA (Health Products Regulatory Authority) and EMA requirements.

1.2 Regulatory & Compliance

• Adherence to industry regulations (FDA, EMA, MHRA, GMP, GLP, GCP, etc.).
• Adherence to EU and Irish pharmaceutical laws (e.g., EudraLex, ICH guidelines, HPRA regulations).
• Regulatory submissions and approvals via HPRA, EMA, and FDA (if exporting to the U.S.).
• Handling regulatory inspections and audits from the HPRA, EMA, and FDA.
• Ensuring GMP, GDP compliance in manufacturing and distribution.

1.3 Product & Process Control

• Analytical testing and Review.
• Investigation and resolution of out-of-specification (OOS) and non-conformance issues.
• Implementation of Corrective and Preventive Actions (CAPA) as a result of OOS investigations.
• Batch record review and lot release (Qualified Person (QP) certification in Ireland).
• Pharmacovigilance and complaint handling to ensure patient safety.
• Ongoing GMP training and personnel qualification to ensure compliance and competency.

These 3 pillars ensure a structured and effective QA system that meets regulatory requirements while driving high product and process quality.

QA professionals operate across various domains, with responsibilities influenced by multiple factors, including:

• Function and scale of Team:
  • Key areas include Compliance and regulatory, Batch Release & QP, Supplier Quality and Vendor Management, Internal & External Auditing, QMS and Document Control, Deviation and CAPA Management.
  • Smaller teams, one individual could cover the full continuum, whereas in larger teams, specialisation occurs, and hierarchy emerges.

• Product Type:
  • Sterile (Injectables, Ophthalmic, Biologics) v Non-Sterile (Tablets, Capsules, Syrups).
  • Biologics (Vaccines, Monoclonal Antibodies, Gene Therapy) v API (Generics, OTC products).
  • High Risk (Oncology Drugs, Hormones, Blood Products) v Low Risk products (Vitamins, Cosmetics, OTC Medicines).

• Regulatory Scope:
  • Ensuring compliance with guidelines from regulatory bodies such as the EMA, FDA, HPRA, and WHO.

• Company Type:
  • Differences exist between Pharma, Biopharma, Contract Development and Manufacturing Organisations (CDMO), Contract Manufacturing Organisations (CMO), and Generic Pharma companies.

These elements shape the scope of QA roles and impact salary structures across the sector.

#2 Base Salary

*Salaries for both Quality Auditors and QPs vary significantly.  

There are a number of factors that play a critical role in influencing these variations.

For Quality Auditors, Product type and complexity of the product, frequency of travel coupled with base locations of suppliers will significantly impact salary.

For a QP, salaries differentiate depending on whether an individual is purely QP Qualified with no licence experience versus a QP who has experience working under a license as a QP. Having licence experience is becoming a key requirement for hiring companies. These companies may have QP qualified talent within their Quality Team, but who are lacking the necessary licence experience.

In recent years there has been a large uptake in QA Professionals undertaking QP courses.

Salary levels in QA are determined by a number of factors. Below I have categorised them specifically in relation to internal and external factors:

Some of which are already mentioned above.

• Internal Factors:
  • Function of Team:
    • QA teams that focus on specialised functions (e.g. QP, Aseptic QA, Sterility assurance, QA Auditing) often require highly skilled professionals, leading to higher salaries. More general QA roles may not command the same premium.
  • Regulatory Complexity:
    • Teams directly responsible for ensuring compliance with strict regulations (e.g. Qualified Person (QP) teams or audit teams dealing with global regulatory bodies like the FDA or MHRA typically earn more due to the critical nature of their work.
  • Size of Team:
    • In smaller teams, individuals may take on broader responsibilities, which can justify higher pay. In larger teams, roles may be more segmented, affecting salary depending on whether a role is strategic or operational.

• External Factors:
  • Demand vs. Supply:
    • The availability of skilled QA professionals impacts salary competitiveness within the industry.
  • Industry Trends:
    • The increasing focus on digitalisation, automation, and data integrity in QA influences the demand for specialised skill sets.

#3 Demand vs. Supply / Talent Availability

As the pharmaceutical sector continues to maintain a strong performance, the demand for qualified QA professionals remains consistently high.

Quality Auditors and QP talent remain in high demand.

#4 Conclusion

Barden’s “Quality Assurance Talent Monitor Q2 2025” highlights the evolving landscape of QA roles within the pharmaceutical industry in Ireland. Understanding the interplay of internal job functions, external market trends, and salary benchmarks is crucial for both employers and professionals navigating this competitive field.

In Barden, we understand that each team, role, and requirement is unique. If you would like to discuss what tactics and approaches that would suit you, please feel free to contact Aidan Crowley our Quality Assurance Talent Advisory & Recruitment expert here in Barden (aidan.crowley@barden.ie); we’re where leaders go before they start looking for Quality Assurance talent.

This information is accurate as per April 2025 and will be updated periodically. Data sources include Barden Proprietary Data, LinkedIn Analytics and other 3rd party data sources.  If you have a request and would like real-time information to inform your hiring decisions contact Aidan Crowley at aidan.crowley@barden.ie