We're seeking a
Quality Systems/Sanitation Design Manager to lead and strengthen quality systems in an FDA-regulated manufacturing environment. This role is ideal for a quality professional who pairs deep regulatory expertise with
high emotional intelligence and the ability to build trusted relationships across all functions of the organization.
What You'll Do- Lead and continuously improve FDA-compliant quality systems
- Manage deviations, non-conformances, investigations, and CAPA using a risk-based, collaborative approach
- Own and oversee change management, document control, internal audits, customer complaints, and product release processes
- Partner closely with Manufacturing, Operations, Quality Assurance, and Leadership to ensure compliance is practical, effective, and sustainable
- Serve as a key leader during regulatory inspections and customer audits
- Coach and develop team members while fostering a culture of accountability, transparency, and continuous improvement
What You Bring- Bachelor's degree in a scientific or engineering discipline (advanced degree preferred)
- 7+ years of experience with manufacturing quality systems
- 3+ years in a leadership or advisory role, with 5+ years of interaction with regulatory agencies
- Strong working knowledge of investigations, audits, change management, and regulated documentation systems
- High emotional intelligence, with a proven ability to influence, communicate effectively, and build strong cross-functional relationships
- Ability to navigate difficult conversations and balance regulatory compliance with business needs
Why This RoleThis is more than a compliance role - it's an opportunity to
shape quality culture through partnership, credibility, and leadership. You'll play a critical role, supporting operations, and driving meaningful, sustainable improvement across the organization.
