G&L Leadership Reflections - Organization design - Paul Kuiken

In today's dynamic regulatory landscape, pharmaceutical companies are faced with a multitude of challenges – from navigating post-Covid realities to addressing clinical trial failures and managing the complexities of mergers and acquisitions.

Amidst these challenges, it's not uncommon for companies to resort to cost-cutting measures as a first step, often employing blunt instruments like headcount reduction and offshoring activities to low-cost locations.

While these may seem prudent on the surface, they can have detrimental effects on organizational performance, resulting in the loss of critical resources and capabilities needed to drive success.

At G&L Healthcare Advisors, we've witnessed firsthand the impact of such top-down initiatives, particularly within regulatory and quality departments.

These areas, vital to the success of pharmaceutical R&D, often find themselves caught between a rock and a hard place when faced with resource constraints.

A reduction in resources or loss of product knowledge can lead to compliance issues and missed filings, jeopardizing the company's reputation and bottom line.

However, there's a better way forward.

We firmly believe that good organizational design naturally drives costs out of the business by fostering alignment across the organization. By aligning people, processes, and systems towards a common, customer-/patient-centric objective, waste and inefficiency are eliminated, and productivity is increased.

This relentless focus on alignment empowers regulatory and quality groups to stop non-value-added activities and streamline processes, ultimately leading to significant efficiency savings.

In numerous organization design projects, we've identified inconsistencies in sub-group activities that, when addressed, resulted in more than 20 percent savings.

By aligning resources towards common objectives, we've consistently seen double-digit productivity increases, along with reductions in management, administrative, and training time.

Moreover, teams aligned and focused on common objectives are more likely to be committed to change programs, ensuring the success of organizational transformations.

But our approach offers more than just cost savings.

It provides a sound foundation for change and enables other initiatives, such as digital technology enablement and service design implementation, to work more effectively.

With a fundamental understanding of the business of Regulatory Affairs, we work closely with our clients to develop bespoke solutions tailored to their unique challenges and objectives.

Our services include:

• Assessing and implementing purpose, strategy, and objectives aligned with the corporation
• Ground-up (or ‘zero-based’) design
• Future-proofing your organization through gap and risk analysis, planning, and digital preparedness
• Accompanying change programs
• Customer experience, service design, and value demonstration
• Service delivery optimization, balancing quality, and cost objectives
• Strategic resource deployment and sourcing
• Process simplification and excellence programs (Lean and Six Sigma)

For further information, visit our website www.gandlhealth.com, or contact us today: hello@gandlhealth.com

Paul Kuiken is Vice President of Advisory Practice at G&L Healthcare Advisors.

Over the last three decades, Paul has worked across a broad range of disciplines including process engineering, quality assurance, regulatory affairs, business development, and commercial operations management.

A member of TOPRA for over 20 years, he has enjoyed several voluntary roles with the body including editorial board member for Regulatory Rapporteur, working in the MSc Regulatory Affairs Module 9 Working Party, and as a Biotech SPIN member.

Paul completed his Global Executive MBA at the prestigious Henley Business School in 2023.