Quality Manager

The Quality Manager leads the Quality Assurance and Quality Control departments and oversees quality systems supporting manufacturing, packaging, warehousing, and related business functions. This position ensures products and processes meet applicable regulatory requirements, current Good Manufacturing Practices (cGMP), established quality standards, and customer specifications.

The Quality Manager partners with departmental leaders to strengthen compliance, resolve quality issues, improve processes, and promote a culture of quality, accurate documentation, and accountability.

• Lead the QA and QC departments, including employee training, development, and performance management.
• Lead regulatory inspections, customer audits, and third-party audits in coordination with the Senior Director of Quality.
• Partner with the QMS Manager to maintain effective quality systems, controlled documentation, and compliance with applicable regulations and cGMP requirements.
• Manage customer complaints, quality investigations, root-cause analysis, and corrective and preventive actions.
• Review and approve deviations, change controls, and material dispositions within established approval authority.
• Oversee material traceability, quarantine, rework, label control, and the removal of obsolete materials and documentation.
• Oversee equipment qualification and maintain accurate quality records, manufacturing documentation, and related databases.
• Collaborate with internal teams, suppliers, and external partners on supplier qualification, quality agreements, and product quality requirements.
• Evaluate quality trends, strengthen procedures and training, and drive continuous improvement across departments.
• Inspect products, materials, and labels against established specifications, including evaluating color variations, and promptly communicate quality concerns and product holds.
• Perform other related duties and participate in quality and continuous improvement projects as assigned.

• Bachelor’s degree in a relevant scientific or technical discipline.
• At least five years of direct experience in a GMP manufacturing environment.
• At least three years of management experience in a GMP environment, which may overlap with the overall experience requirement.
• Experience with quality systems, audits, investigations, corrective and preventive actions, deviations, change control, and controlled documentation.

• Strong leadership, coaching, and performance-management skills.
• Effective written and verbal communication skills.
• Ability to collaborate across departments and address quality concerns constructively.
• Strong analytical, organizational, and problem-solving skills.
• Attention to detail and sound judgment when reviewing records, assessing risks, and making quality decisions.
• Ability to distinguish colors and identify color variations, including differences between green and blue, when inspecting products, materials, or labels against established quality specifications, with or without reasonable accommodation.
• Proficiency with Microsoft Office and the ability to use enterprise and electronic quality management systems effectively.
• Ability to prioritize responsibilities and communicate time-sensitive concerns promptly.

• Model ethical conduct, accurate documentation, and adherence to quality requirements.
• Encourage employees to raise quality concerns and suggest improvements.
• Establish clear expectations and support accountability through training, coaching, and follow-through.
• Collaborate with departmental leaders to resolve process gaps and recurring issues.
• Initiate improvements through approved procedures and change-control processes.
• Use enterprise…