How Crucial Is A Quality Focused Function In Manufacturing and Commercial Businesses?

Quality Assurance in Life Sciences

As the APAC Recruitment Consultant at Barrington James, the largest dedicated Global Life Science and Pharmaceutical search firm, I am part of a team that specializes in placing senior professionals in crucial roles such as Quality Assurance (QA) and Quality Control (QC). Since leading the Quality Desk here, I’ve successfully appointed senior QA professionals across GMP, GDP, and GLP in the Pharmaceutical, Biotechnology, and Medical Device sectors.

During the 2020 pandemic, I discovered a growing niche for Senior Lab Managers and Lab Managers skilled in accrediting Molecular Diagnostics labs for COVID-19 testing capabilities. This has only reinforced the importance of QA in ensuring industry standards and patient safety.

What Defines Quality Assurance in Life Sciences?

Quality Assurance is essential in life sciences, where stringent standards are crucial for ensuring the safety and efficacy of drugs or medical devices. QA is proactive—it focuses on preventing issues rather than reacting to them. This includes functions like corporate compliance, GxP compliance (across manufacturing, distribution, laboratory, clinical), computer systems validation, and supplier quality engineering.

Market Insights

Despite the critical role QA plays, it can sometimes be misunderstood. The public purpose of QA is to safeguard health, and with that comes a need for strict adherence to standards. However, within some organizations, QA is occasionally perceived as a “hindrance,” slowing down processes and impeding efficiency. This misunderstanding can impact how QA is viewed, making the role challenging for personnel who work diligently to protect public safety.

Why Quality is Valuable in Manufacturing

Quality in manufacturing minimizes preventable deviations and allows for easier correction of non-compliances before products are manufactured in bulk. Proactive audits and corrective actions (CAPA) ensure standards are met early in the process. If defects are identified after mass production, product recalls can be costly, resulting in financial losses and reputational harm.

The Role of Quality in Commercial Businesses

In distribution, upholding Quality standards is crucial to maintaining a strong brand reputation, which directly supports revenue generation. Adherence to QA standards in distribution builds trust and reliability, enabling companies to retain and grow their market presence.

Challenges of Not Valuing the Quality Function

When Quality isn’t prioritized, there’s a risk of non-compliance with safety and regulatory standards. QA professionals may feel undervalued, affecting morale and retention rates. This can lead to a loss of talent, further hindering a company’s ability to uphold quality standards.

Conclusion

To create a culture where quality is upheld, all departments within a business must proactively govern and support Quality standards—not leave it solely to the QA team. When integrated into every area, the Quality function is empowered to prevent issues, reduce defects, and ensure safe and effective products and services for consumers.

If your organization needs assistance placing senior Quality professionals across GMP, GDP, and GLP within the Pharmaceutical, Biotechnology, and Medical Device industries, feel free to connect with me.

Contact: WanYun Nie