VP of Quality

Emerging-Stage CDMO - USA

Highlight

Improved compliance and scaled regulatory infrastructure for growth

The Brief

A CDMO specializing in niche formulations and clinical trial supply engaged us to identify a Vice President of Quality who could modernize its systems and prepare the business for increased regulatory scrutiny. As the company scaled manufacturing to support multiple early-phase clinical programs, leadership recognized the need for a senior Quality executive who could ensure compliance while enabling growth. The mandate was to bring in a leader capable of building a scalable Quality Management System, elevating audit readiness, and serving as the company’s primary interface with regulators.

The Challenge

The company had recently taken on several new programs requiring GMP readiness, yet it lacked a senior Quality presence with direct FDA engagement experience. The business environment demanded a candidate who could operate effectively in a resource-constrained setting, balancing strategic oversight with hands-on implementation. Many seasoned Quality leaders were accustomed to larger organizational infrastructures and were less suited to the entrepreneurial agility required here. Conversely, candidates from smaller companies often lacked exposure to regulatory engagement at the level needed to prepare for inspections. The challenge was therefore to find a professional who could both design and execute improvements to the Quality system while commanding credibility with auditors and clients.

Our Approach

We conducted a focused search targeting Quality leaders from small to mid-sized CDMOs and pharmaceutical companies who had built or transformed Quality Management Systems during scale-up. Special consideration was given to individuals with experience leading QA and QC functions through FDA pre-approval inspections, client audits, or remediation processes. Each candidate was evaluated on four key dimensions: regulatory engagement experience, track record of implementing risk-based quality systems, leadership style suited to resource-constrained teams, and the ability to integrate quality strategy with broader operational goals. Our outreach was discreet and referral-led, ensuring we engaged candidates who were both technically credible and motivated by the opportunity to shape quality culture in a high-growth environment.

Outcome

Within the search period, we placed a Vice President of Quality who had previously implemented risk-based quality systems at a similarly sized CDMO and successfully led FDA audit readiness efforts. Since joining, the new leader has introduced more robust governance practices, strengthened internal compliance culture, and improved the company’s performance during client audits. The appointment has provided the leadership team with confidence that the business can scale its manufacturing footprint while maintaining regulatory credibility, giving clients and investors assurance that growth is supported by a strong compliance framework.

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Sanderson House,
22 Station Road, Horsforth, Leeds.
LS18 5NT.
United Kingdom

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