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Quality Manager
Quality ManagerHarba Solutions Inc. • Indianapolis, IN, United States
Quality Manager

Quality Manager

Harba Solutions Inc. • Indianapolis, IN, United States
4 days ago
Job type
  • Full-time
Job description

Job Responsibilities

  • Champions the creation and continuous evolution of a strong quality culture—driving strategy, policy, team objectives, and all warehouse processes that influence Quality Assurance, in partnership with clients.
  • Interprets and applies GxP regulations and policies to complex and often unique operational challenges.
  • Oversees internal and external audits—both routine and non-routine—as well as quality initiatives related to regulatory inspections and findings of potential non-compliance.
  • Collaborates with the Operations Manager to manage resources, priorities, schedules, and projects to ensure all operational quality objectives are met.
  • Leads projects, programs, and team development efforts that carry GxP compliance implications.
  • Fosters a work environment that enhances employee engagement, productivity, and participation while strengthening value delivery to clients.
  • Develops the warehouse operations team’s capabilities and knowledge to maintain compliance with evolving regulations and shifting client expectations for quality.
  • Directs one or more direct reports and / or manages matrixed teams or business processes essential to the quality program.
  • Actively participates in risk-management efforts—identifying risks, escalating concerns, and implementing effective mitigation strategies.
  • Serves as a coach, mentor, and trainer to cultivate a strong quality mindset across the organization.
  • Proactively identifies and communicates business or regulatory changes that may affect the quality standing of warehouse operations.
  • Provides actionable recommendations and collaborative solutions that demonstrate measurable quality improvement for internal and external stakeholders.
  • Engages with the business on strategic and operational decisions on behalf of clients.

Qualifications

  • 6+ years experience in Quality Operations
  • Bachelors degree in STEM preferred
  • Prepares and presents quarterly account-level quality performance reports to organizational leadership.
  • Manages and coordinates quality audits and regulatory inspections.
  • Represents the organization in customer meetings and quarterly business reviews, providing updates on operational quality performance.
  • Continuously monitors CQAs and CPPs throughout the operation and recommends policy or procedural enhancements to maintain world-class quality standards.
  • Acts as the primary point of contact for client quality requests—including reporting, investigations, training updates, inspections, and CAPA activities.
  • Ensures exceptional responsiveness to both routine and non-routine client requests involving data, reporting, fulfillment, customer support, problem resolution, investigations, and other operational or quality initiatives.
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