Senior Director, Quality Assurance

What You'll Do

• Lead the Quality Assurance function for assigned manufacturing sites.
• Develop and promote a strong quality culture focused on continuous improvement.
• Partner with Operations to implement standardized quality processes and best practices across locations.
• Serve as the primary quality contact for customers and regulatory agencies.
• Lead customer communications and resolution of quality concerns.
• Escalate significant quality issues to executive leadership as appropriate.
• Strengthen and continually improve the Quality Management System (QMS), including CAPA processes.
• Develop organizational structures, systems, and processes that drive execution and accountability.
• Establish and oversee GMP and regulatory training programs.
• Monitor and report Quality KPIs to senior leadership.
• Ensure compliance with corporate standards, SOPs, FDA regulations, and applicable quality requirements.
• Lead audits, corrective actions, documentation, and follow-up activities.
• Develop, coach, and mentor Quality leaders and team members.
• Manage departmental budgets, performance reviews, and strategic workforce planning.
• Support business objectives related to safety, quality, productivity, and cost.

Required Qualifications

• Bachelor's degree in Life Sciences or a related field.
• 10+ years of quality experience within a regulated industry such as:
  • Pharmaceuticals
  • Cosmetics
  • Medical Devices
  • Biologics
  • Laboratory Operations
• Experience within a contract manufacturing organization (CMO/CDMO) strongly preferred.
• Minimum of 5 years of leadership experience managing professional or exempt-level teams.
• Strong working knowledge of:
  • FDA regulations
  • Good Manufacturing Practices (GMP)
  • CAPA systems
  • Quality Management Systems (QMS)
  • Regulatory compliance
• Proven ability to lead organizational change and continuous improvement initiatives.

Preferred Qualifications

• Experience supporting multiple manufacturing sites.
• Customer-facing quality leadership experience.
• Strong background in quality metrics, audits, inspections, and regulatory interactions.
• Experience building and developing high-performing quality organizations.

Skills That Will Help You Succeed

• Executive leadership and strategic thinking
• Quality systems expertise
• Regulatory compliance
• Customer relationship management
• Cross-functional collaboration
• Continuous improvement mindset
• Root cause analysis and problem solving
• Coaching and talent development
• Excellent written and verbal communication
• Project and priority management

Working Environment

This position is based in a manufacturing environment with a combination of office and production floor responsibilities. Candidates should be comfortable spending time in manufacturing areas and occasionally lifting up to 25 pounds.