Senior Director Quality

Reporting to the CEO, our customer wish to appoint a Senior Director of Quality who will lead all aspects of the businesses quality strategy as it embarks on an ambitious growth and development journey. This individual will lead a small team of quality professionals, as the business modernises and professionalises key aspects of its quality infrastructure to support a high growth environment.

Key Responsibilities

• Provide strategic leadership of the Quality Management System (QMS) in compliance with ISO 13485 and ISO 11135 and transition to a digital platform.
• Serve as a visible, vocal leader of quality across the organization—building a culture where quality is integrated into all activities and functions.
• Manage, mentor, and develop a quality team, ensuring high performance and growth.
• Implement and continuously improve processes for current and future service offerings.
• Lead Management Review meetings, ensuring clear communication of quality metrics and accountability for improvement.
• Work with external partners on regulatory and environmental activities, representing the company externally as the senior quality leader in interactions with customers, suppliers, auditors, and regulators.

Qualifications

• 10+ years of leadership in a Quality function, preferably in CDMO or CMO or contract laboratory services.
• Familiarity with ISO 13485, 21 CFR Part 820, IEC 62304, 9001 and/or related standards.
• Demonstrated track record of continuous improvement.
• Experienced manager of people and organizational design.
• Strong executive communication, cross-functional alignment, and problem-solving skills.
• Able to travel as necessary for supplier audits.

Leadership Competencies

We are looking for an inspirational leader who energizes and motivates people to embrace quality as a core value. Someone who will hold themselves and others responsible for meeting quality commitments, shaping behaviors and decisions across Operations, Manufacturing, Supply Chain, and R&D.

This person will be an agent of change, driving cultural and process transformation, engaging people on a change journey. They will clearly articulate quality expectations and outcomes to employees at all levels, the executive team, regulators, and customers.

Candidates will demonstrate strength of will in maintaining compliance and quality standards under pressure, and resilience on the change journey. The role requires a balance between immediate compliance and long-term growth and scalability of quality systems, with candidates needing to show their skills in navigating such a landscape.

If this sounds like the kind of challenge that plays to your skillset, then we want to hear from you. To express your interest please email harley@leadcandidate.com with your resume.