Senior Director Quality

Stanley Cowton International; Columbus (OH); On-site; USD 180,000 - 260,000; Full time

Job summary

Stanley Cowton International is seeking a Senior Director of Quality Assurance to lead the Quality function at a major FDA-regulated manufacturing site in Columbus. This is a high-profile, impact-driven role reporting to the SVP of Global Quality, overseeing QA and Microbiology operations and driving a culture of excellence.

The position emphasizes quality transformation, leadership development, and strategic collaboration with operations and executive leadership to elevate performance and

Qualifications

• Experience leading QA in FDA-regulated manufacturing environments.
• Proven ability to drive quality culture and continuous improvement.
• Strong leadership and mentoring capabilities across large teams.

Responsibilities

• Lead QA and Microbiology operations and ensure GMP compliance.
• Oversee audits, regulatory inspections, and customer interactions.
• Develop quality strategy, KPIs, and improvement plans.

Skills

Quality leadership

Regulatory liaison

People development

Education

Master's degree in Life Sciences or related field

Tools

Quality Management System (QMS)

CAPA tracking

Job description

Are you a quality leader who enjoys building, improving, and transforming rather than simply maintaining?

We're supporting a large FDA-regulated manufacturing business on the appointment of a Senior Director of Quality Assurance. This is a high-profile leadership opportunity for someone who wants to make a genuine impact within a complex, fast-paced manufacturing environment.

Reporting directly to the SVP of Global Quality, this individual will lead the site's Quality function, oversee both QA and Microbiology operations, and play a key role in driving quality culture, compliance, customer satisfaction, and continuous improvement.

Why This Opportunity?

This is not a "steady-state" quality role.

The business is performing well and moving in the right direction, but there is a clear mandate to elevate the quality organisation, strengthen leadership capability, improve systems and processes, and continue building a culture of accountability and excellence.

The successful candidate will have the opportunity to:

• Lead a critical quality function within a highly regulated manufacturing environment
• Develop and mentor an established team and future leaders
• Drive quality transformation and continuous improvement initiatives
• Modernise processes and challenge legacy ways of working
• Act as the senior quality representative with customers and regulatory bodies
• Partner closely with operations and executive leadership to influence business performance
• Position themselves for future progression into broader site, operational, or corporate leadership roles

Key Responsibilities

• Lead Quality Assurance and Microbiology functions
• Drive GMP compliance and quality culture across the site
• Manage customer quality relationships and regulatory interactions
• Lead audits, inspections, investigations, CAPA, and quality systems activities
• Develop quality strategy, KPIs, and performance improvements
• Build organisational capability through coaching, leadership development, and succession planning
• Partner with operations to improve quality, efficiency, and customer satisfaction

What We're Looking For

• Significant quality leadership experience within an FDA-regulated manufacturing environment
• Strong understanding of both Quality Assurance and Microbiology/Laboratory operations
• Experience within industries such as personal care, cosmetics, pharmaceuticals, biologics, food & beverage, medical devices, or contract manufacturing
• Strong knowledge of GMP, Quality Systems, CAPA, and regulatory compliance
• Experience leading customer audits and regulatory inspections
• Proven ability to lead teams through change, transformation, and continuous improvement initiatives

The Person

We're looking for a resilient, hands-on leader who enjoys solving problems, developing people, and driving meaningful change.

You’ll be comfortable operating at every level of the organisation, from coaching frontline teams to presenting to senior executives, customers, and regulatory agencies.

Most importantly, you’ll be someone who sees opportunity where others see challenge.