Director of People & Quality Systems

POSITION PURPOSE

The Director of People & Quality Systems is a member of True Function Laboratory's leadership team responsible for the company's People/HR, Quality & Regulatory, and organizational management systems. The role builds a compliant, accountable, high-performing organization and scalable systems that reduce unnecessary dependence on the CEO.

The Director serves as the senior internal HR resource and designated Quality Management Representative when appointed. The Director also serves as True Function's internal EOS champion, working with an external EOS Implementer/coach to integrate and sustain the system throughout the organization.

CORE RESPONSIBILITIES

PEOPLE & HUMAN RESOURCES

• Lead HR systems, employee relations, policies, employment compliance, recruiting, onboarding/offboarding, performance management, and employee development.
• Coach managers on performance, accountability, documentation, corrective action, and employee-relations matters while maintaining manager ownership of their teams.
• Support workforce planning, leadership development, succession planning, engagement, culture, HR records, metrics, and coordination with outside HR/legal resources.

QUALITY & REGULATORY

• Serve as Quality Management Representative when designated and provide leadership and oversight of the company's Quality Management System and regulatory activities.
• Oversee Management Review, CAPA, internal audits, quality objectives/KPIs, training compliance, regulatory readiness, continuous improvement, and significant quality/regulatory risk escalation.
• Lead designated Quality/Regulatory personnel, maintain appropriate Quality independence, and partner with Operations to ensure QMS requirements are effectively implemented without assuming day-to-day production ownership.

ORGANIZATIONAL SYSTEMS / EOS

• Serve as True Function's internal EOS champion and partner with the external EOS Implementer/coach to support implementation and ongoing adoption.
• Reinforce discipline around the Accountability Chart, Scorecards, Rocks/priorities, Issues Lists, meeting cadence, measurable expectations, accountability, and follow-through.

QUALIFICATIONS

• Bachelor's degree in HR, Business, Quality, Regulatory Affairs, Organizational Development, Life Sciences, or related field preferred; equivalent relevant experience considered.
• 5+ years of progressive HR, Quality/Regulatory, or organizational leadership experience preferred, with demonstrated management/leadership experience.
• Strong competency in both People/HR and Quality/Regulatory systems; experience in medical device, dental, healthcare, laboratory, regulated manufacturing, or a similar environment strongly preferred.
• Working knowledge of QMS, audits, CAPA, Management Review, regulatory compliance, employee relations, and performance management; California HR experience strongly preferred.
• Experience with EOS or another structured business operating system preferred; ability to become True Function's internal EOS champion required. Relevant HR, Quality, or Regulatory certification preferred but not required.

SUCCESS FACTORS

Strong judgment, integrity, confidentiality, direct communication, organization, leadership, accountability, and follow-through. Able to balance employee needs, regulatory requirements, quality, operational realities, and business objectives while maintaining clear functional boundaries.

Success means: effective managers, strong HR systems, an audit-ready and continuously improving QMS, clear Quality/Regulatory ownership, consistent EOS adoption, improved organizational accountability, and concise CEO visibility into significant people, quality, regulatory, and organizational risks.