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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Quality Manager • Indianapolis, IN, United States
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