Hiring Your Head of Quality - Borrow or Build?

Deciding the right time to bring on a full-time Head of Quality can be challenging. There are many factors contributing to such a key leadership decision. While the leadership role is being considered, there is likely a gap in Good Practice Guidelines and Regulations (GxP) activities, so an interim Head of Quality may be the solution for your organization in the short term. Let’s take a closer look.

Challenges in Hiring a Head of Quality

One of the initial challenges of hiring a full-time Head of Quality is that it can be time-consuming to review a pile of resumes, schedule rounds of interviews, and ensure the candidate has the right breadth of experience in a specific therapeutic area or across the spectrum of GxP quality activities within any given organization.

Another challenge is often related to a sponsor’s funding, contributing to the prioritization and timing of the hire. Also, there are other key executive roles that are commonly hired before the Head of Quality.

I've also observed that determining the reporting line can sometimes be challenging to maintain the independence of the quality function, while also trying not to over-complicate the organizational structure.

Pros and Cons of Outsourcing (vs. Full-Time Hire)

Pros

Startup GxP activities often require limited quality oversight, so there is typically no need for a full-time employee. An interim Head of Quality allows the sponsor to be nimble and tactical with a seasoned quality expert. Many of our clients with a fully outsourced business model rely heavily on the Quality Management System (QMS) and the quality team of their vendors. Always remember that sponsors are still responsible for demonstrating oversight of these activities and will eventually need their own quality Subject Matter Expert (SME) in place as their development and processes evolve.

As an Interim Head of Quality, Halloran often supports the hiring process. When the time is right to bring on a full-time quality leader, Halloran supports the process by creating the job description for the role and can contribute to the interview process by assessing a quality candidate’s real-world experience and technical capabilities.

Cons

Securing a Head of Quality early on helps to establish a culture of quality within the organization, showing quality is a priority, therefore, any delay in bringing that role in-house may lead to a negative impression within the organization, both to vendors and potential partners.

How Halloran Navigated Quality Leadership Excellence with a Client

Recently completing a two-year engagement with a cell therapy client as their Interim Head of Quality, I was originally brought on to perform vendor qualification audits of their drug substance and drug product Contract Development and Manufacturing Organization (CDMOs) before their needs quickly evolved. We then expanded the engagement into the Interim Quality Leadership role, taking a hands-on approach to collaborate with functional leaders and key vendors, becoming a member of the operational leadership team and fully embedded within clinical operations and manufacturing project teams.

We also added a quality document development project to build their QMS, GxP training, and Clinical Research Organization (CRO) vendor qualification. As we approached GMP manufacturing and the release of clinical investigational product to patients, the hours of support were scaled up to meet the need.

A full-time Head of Quality was recently hired, and I stayed on to support the new leader’s acclimation and transition into the role. In summary, there are many benefits to hiring an interim Quality Leader at a time of dynamic growth within an organization to create stability and continue to drive key business outcomes.

To learn more about Halloran’s GxP Quality Leadership expertise as well as our full Quality and Compliance capabilities including QMS development, Compliance Remediation, Vendor Selection and Management, Inspection Readiness, and Training services, contact us.