Lead Candidate
The Senior Director of Quality is a senior leadership role responsible for driving a culture of quality across the organization.
Beyond managing compliance with ISO 13485, ISO 11135, and related standards, this individual will be the company’s champion for Quality, driving a culture where everyone takes responsibility for quality.
Leading a small team of quality professionals, they will be accountable for quality standards, and inspire employees at every level to integrate quality into their daily work. The role includes transitioning to a digital QMS platform, conducting gap assessments, and implementing enhancements required to achieve compliance with additional standards (ISO 14937, ISO/IEC 17025).
Key Responsibilities
Provide strategic leadership of the Quality Management System (QMS) in compliance with ISO 13485 and ISO 11135.
Lead gap assessments and implement processes to expand compliance with additional standards (ISO 14937, ISO/IEC 17025).
Serve as a visible, vocal leader of quality across the organization—building a culture where quality is integrated into all activities and functions.
Hold individuals and departments outside of Quality accountable for compliance with quality processes and standards.
Manage, mentor, and develop a quality team, ensuring high performance and growth. Drive the transition to a digital QMS system, including selection, implementation, and training.
Oversee implementation and use of electronic software systems for batch record and compliance tracking.
Implement and continuously improve processes for current and future service offerings.
Develop and maintain systems to support ISO/IEC 17025 laboratory certification and ongoing compliance.
Plan, lead, and manage all internal audits, supplier audits, and audits by regulators, customers, and notified bodies.
Lead Management Review meetings, ensuring clear communication of quality metrics and accountability for improvement.
Coordinate limited regulatory and environmental quality activities, leveraging external consultants as appropriate.
Represent 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.
Inspirational Leadership – energizes and motivates the organization to embrace quality as a core value.
Accountability – holds self and others across all functions responsible for meeting quality commitments.
Cross-Functional Influence – effectively leads beyond the Quality team, shaping behaviors and decisions in Operations, Manufacturing, Supply Chain, and R&D.
Change Leadership – drives cultural and process transformation, engaging people on a change journey.
Communication Excellence – clearly articulates quality expectations and outcomes to employees at all levels, the executive team, regulators, and customers.
Resilience and Resolve – demonstrates strength of will in maintaining compliance and quality standards under pressure.
Strategic Vision – balances immediate compliance needs with long-term growth and scalability of quality systems.
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Beyond managing compliance with ISO 13485, ISO 11135, and related standards, this individual will be the company’s champion for Quality, driving a culture where everyone takes responsibility for quality.
Leading a small team of quality professionals, they will be accountable for quality standards, and inspire employees at every level to integrate quality into their daily work. The role includes transitioning to a digital QMS platform, conducting gap assessments, and implementing enhancements required to achieve compliance with additional standards (ISO 14937, ISO/IEC 17025).
Key Responsibilities
Provide strategic leadership of the Quality Management System (QMS) in compliance with ISO 13485 and ISO 11135.
Lead gap assessments and implement processes to expand compliance with additional standards (ISO 14937, ISO/IEC 17025).
Serve as a visible, vocal leader of quality across the organization—building a culture where quality is integrated into all activities and functions.
Hold individuals and departments outside of Quality accountable for compliance with quality processes and standards.
Manage, mentor, and develop a quality team, ensuring high performance and growth. Drive the transition to a digital QMS system, including selection, implementation, and training.
Oversee implementation and use of electronic software systems for batch record and compliance tracking.
Implement and continuously improve processes for current and future service offerings.
Develop and maintain systems to support ISO/IEC 17025 laboratory certification and ongoing compliance.
Plan, lead, and manage all internal audits, supplier audits, and audits by regulators, customers, and notified bodies.
Lead Management Review meetings, ensuring clear communication of quality metrics and accountability for improvement.
Coordinate limited regulatory and environmental quality activities, leveraging external consultants as appropriate.
Represent 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.
Inspirational Leadership – energizes and motivates the organization to embrace quality as a core value.
Accountability – holds self and others across all functions responsible for meeting quality commitments.
Cross-Functional Influence – effectively leads beyond the Quality team, shaping behaviors and decisions in Operations, Manufacturing, Supply Chain, and R&D.
Change Leadership – drives cultural and process transformation, engaging people on a change journey.
Communication Excellence – clearly articulates quality expectations and outcomes to employees at all levels, the executive team, regulators, and customers.
Resilience and Resolve – demonstrates strength of will in maintaining compliance and quality standards under pressure.
Strategic Vision – balances immediate compliance needs with long-term growth and scalability of quality systems.
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