Position Summary: The Quality Manager leads quality and compliance across multiple distribution centers, warehouses, co-manufacturing partners, and 3PL operations, including facilities in Nashville and New York. This role ensures adherence to quality standards, SOPs, cGMPs, and regulatory requirements while overseeing the quality of raw materials, semi-finished goods, and finished products throughout the supply chain.
As the quality leader for the distribution network, this position drives continuous improvement, manages quality systems and compliance activities, and provides leadership to the Quality Assurance team, including supervisors and inspectors. The successful candidate will build strong cross-functional partnerships and foster a culture of quality, compliance, and operational excellence across all sites.
Key Responsibilities: - Develops team members through ongoing feedback, coaching, counseling, and support.
- Ensures all new and existing associates are trained and remain compliant with current Good Manufacturing Practices (cGMPs) and 21 CFR Part 111 requirements.
- Maintains compliance with FDA regulations and other applicable industry standards.
- Supports and participates in audit preparation and inspections conducted by regulatory and certifying agencies (e.g., FDA, USP). Assists in developing and executing corrective action plans in a timely manner.
- Leads, anticipates, assesses, and manages current and future compliance requirements within Warehouse and Distribution operations.
- Ensures the accurate and timely completion of activities related to packaging materials, bulk and finished goods release, and the maintenance of cGMP and SOP documentation.
- Leads and supports investigations utilizing Root Cause Analysis (RCA) and effective Corrective and Preventive Action (CAPA) methodologies.
- Evaluates data using statistical tools and leads or supports Product Change Control activities.
- Collaborates cross-functionally to implement production changes, system updates, and documentation revisions efficiently and effectively.
- Administers and continuously improves Quality Management Systems (QMS), including Deviations, Non-Conformances, CAPAs, and Change Controls.Analyzes, prepares, and presents quality performance data and trends to leadership.
- Facilitates Material Review activities for nonconforming materials, including disposition determination and appropriate documentation.
- Builds and maintains strong cross-functional and global partnerships to support business objectives and customer needs.
- Leads and administers all site mock recall activities, serving as the subject matter expert for recall readiness, retrieval, and recall processes.
- Demonstrates leadership through effective communication, strong work habits, and proficiency in a broad range of quality and operational processes, including safety, troubleshooting, problem-solving, decision-making, planning, audits, statistical analysis, production control systems, manufacturing documentation review, equipment validation, performance management, and training.
- Applies Statistical Process Control (SPC) methodologies and leverages data-driven insights to improve process performance and product quality.
- Partners with Operations and Technical Services teams to support site initiatives and achieve business objectives and performance targets.
- Serves as a role model for the organization's vision, mission, and values, with a
