Quality Manager (Manufacturing)

Latitude Inc • Mayfield, KY

91d • $90,000 - $110,000

About The Position

The Quality Assurance Manager will lead, develop, and monitor the performance and growth of the Quality Assurance team, ensuring that staffing, training, coaching, and performance evaluations are effectively managed. The role promotes an inclusive, collaborative culture where “everyone owns quality” and team members are empowered to contribute to product excellence and compliance. The manager will manage the Quality Management System (QMS) in compliance with ISO 22716, ISO 9001, FDA regulations, and customer requirements, ensuring that systems are audit-ready at all times. Additionally, the manager will oversee internal audits, deviations, CAPAs, change control, document control, and validation activities to ensure robust quality systems and continuous improvement. The Quality Assurance Manager will serve as the primary quality and regulatory contact for internal teams, customers, and regulatory bodies, leading responses to customer complaints, audits, and inspections. The role involves liaising with customers on product quality, new product introductions, specification alignment, and resolution of quality concerns. The manager will partner cross-functionally with Production, Supply Chain, Regulatory, R&D, and the Lab Manager to solve problems, reduce defects, and improve product and process quality. Monitoring and analyzing KPIs and quality data to drive operational excellence and meet product performance expectations is also a key responsibility. Furthermore, the manager will ensure compliance with cGMP, GLP, Good Documentation Practices, and internal policies, staying current on regulatory changes and implementing updates as required. The role will drive strategic quality initiatives, including cost reduction, efficiency improvements, and risk mitigation, in alignment with company goals and customer expectations. The manager will own product release decisions for raw materials, bulk formulations, and finished goods in partnership with the Lab Manager and senior leadership, support supplier quality management, and represent the Quality function in customer, corporate, and regulatory interactions, leading audit readiness and inspection preparedness efforts. Finally, the manager will develop and manage departmental budgets, resource plans, and capital needs in alignment with operational and compliance priorities.

Requirements

• Bachelor’s degree in relevant fields such as Life Science, Engineering, Chemistry, or related discipline required.
• Minimum of 5 years of experience in quality assurance or a life sciences role (e.g., analytical, microbiological) within a manufacturing environment.
• At least 5 years of management experience or a combination of 7+ years of supervisory and leadership experience.
• Experience working in a regulated environment with strong working knowledge of FDA, EPA, ISO 22716, and other applicable regulatory frameworks.
• Proven track record of leading cross-functional teams and developing talent.

Responsibilities

• Lead, develop, and monitor the performance and growth of the Quality Assurance team, including staffing, training, coaching, and performance evaluations.
• Promote an inclusive, collaborative culture where 'everyone owns quality' and team members are empowered to contribute to product excellence and compliance.
• Manage the Quality Management System (QMS) in compliance with ISO 22716, ISO 9001, FDA regulations, and customer requirements; ensure systems are audit-ready at all times.
• Oversee internal audits, deviations, CAPAs, change control, document control, and validation activities to ensure robust quality systems and continuous improvement.
• Serve as the primary quality and regulatory contact for internal teams, customers, and regulatory bodies, lead responses to customer complaints, audits, and inspections.
• Liaise with customers on product quality, new product introductions, specification alignment, and resolution of quality concerns.
• Partner cross-functionally with Production, Supply Chain, Regulatory, R&D, and the Lab Manager to solve problems, reduce defects, and improve product and process quality.
• Monitor and analyze KPIs and quality data to drive operational excellence and meet product performance expectations.
• Ensure compliance with cGMP, GLP, Good Documentation Practices, and internal policies; stay current on regulatory changes and implement updates as required.
• Drive strategic quality initiatives, including cost reduction, efficiency improvements, and risk mitigation, in alignment with company goals and customer expectations.
• Own product release decisions for raw materials, bulk formulations, and finished goods in partnership with the Lab Manager and senior leadership.
• Support supplier quality management, including specification flow-down, qualification, monitoring, and corrective actions for nonconforming materials.
• Represent the Quality function in customer, corporate, and regulatory interactions, lead audit readiness and inspection preparedness efforts.
• Develop and manage departmental budgets, resource plans, and capital needs in alignment with operational and compliance priorities.

Benefits

• $90,000 - $110,000 a year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees