Quality Assurance Manager

Assure Infusions is seeking an experienced and proactive Quality Manager to lead and strengthen our Quality Team.. This role is critical to ensuring compliance, driving continuous improvement, and maintaining the highest standards of patient safety and product quality.

The Quality Manager will oversee CAPA, deviations, investigations, and the day-to-day management of the Quality Inspector team, serving as a key partner to Operations, our Lab teams, and Compliance teams. The ideal candidate is hands-on, detail-oriented, and confident leading teams in a regulated healthcare environment, but also in a high-growth environment.

Key Responsibilities

Quality Systems & Compliance

• Own, manage, and continuously improve the CAPA program, ensuring root cause analysis is thorough, effective, and timely.
• Lead and approve deviation management, nonconformance investigations, and corrective/preventive actions.
• Ensure investigations are well-documented, risk-based, and compliant with internal procedures and regulatory expectations.
• Maintain and enhance the Quality Management System (QMS), including SOPs, work instructions, and quality records.
• Ensure compliance with applicable regulations and standards (e.g., FDA, state pharmacy regulations, USP, and company policies).

Investigations & Risk Management

• Serve as the primary escalation point for complex quality events and critical investigations.
• Trend and analyze quality data (deviations, CAPAs, audit findings) to identify systemic risks and improvement opportunities.
• Partner with cross-functional teams to implement sustainable corrective actions.

Quality Inspection & Team Leadership

• Directly manage and mentor the Quality Inspector team, providing clear expectations, coaching, and performance feedback.
• Assign and prioritize inspection activities to ensure timely support of operations.
• Develop and deliver training to ensure inspectors are qualified, consistent, and inspection-ready.
• Foster a culture of quality, accountability, and continuous improvement.

Audits & Continuous Improvement

• Lead internal audits and support external audits and inspections.
• Ensure audit observations are appropriately addressed and closed on time.
• Drive quality improvement initiatives across the organization.

Qualifications

Required

• Bachelor’s degree in a scientific, healthcare, or quality-related discipline (or equivalent experience).
• 5 years of Quality Assurance experience in a regulated healthcare, pharmaceutical, compounding, or infusion environment.
• Demonstrated experience managing CAPA, deviations, and investigations.
• Prior people management experience, preferably leading inspectors or QA staff.
• Strong understanding of quality systems, documentation standards, and regulatory compliance.
• Excellent analytical, organizational, and written communication skills.

Preferred

• Experience in infusion services, pharmacy compounding, or sterile environments.
• Lean, Six Sigma, or quality certification (e.g., ASQ) is a plus.

Why Join Assure Infusions?

Assure Infusions offers the rare opportunity to make a meaningful impact in an exciting, fast-growing start-up environment where your ideas, leadership, and expertise truly matter. You’ll help shape and strengthen the organization while gaining access to hands-on training, professional development, and clear opportunities for growth. Our mission-driven team is focused on addressing the nation’s critical IV drug shortages—work that directly supports healthcare providers and improves patient outcomes across the country. At Assure Infusions, you’re not just filling a role—you’re helping build a company that improves lives and advances the future of infusion care.

On top of that you will be joining a great team, get to be a part of a growing organization where our open door policy actually means short communication lines, honest conversations and genuine exchanges.