Job Description

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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