Manager Quality

- - **General Summary** This position is responsible for establishing, maintaining, and continuously improving the assigned Quality Management System (QMS) to ensure compliance with applicable regulatory, contractual, and customer requirements. This role provides leadership to Quality Supervisors and team members, serves as the site Management Representative for regulated environments (as applicable), and acts as the primary quality liaison with customers, auditors, and regulatory bodies. This position partners with site leadership to drive a culture of quality, risk-based decision-making, and continuous improvement. **Primary Responsibilities** - Management responsibilities include, but are not limited to hiring, coaching, skills development, recognition and rewards, labor planning and forecasting, staff productivity and performance management to include disciplinary actions up to and including termination. - Serve as the site Management Representative for regulated environments (as applicable), with responsibility for the effectiveness, maintenance, and improvement of the Quality Management System. - Establish, implement, and maintain site quality policies, procedures, and work instructions in alignment with regulatory and customer requirements. - Provide leadership and oversight for inspections, product quality determinations, inventory disposition, and WMS product status controls. - Ensure consistent application of quality standards, decision frameworks, and escalation pathways across operations - Act as the primary site contact for customer quality matters, audits, and regulatory inspections. - Oversee and approve quality investigations, root cause analysis, corrective and preventive actions (CAPA), and effectiveness checks. - Ensure compliance with documentation, data integrity, record retention, and change control requirements. - Lead risk assessments and quality planning activities related to new customers, products, processes, or system changes. - Oversee validation and qualification activities, including equipment and systems validation, warehouse temperature mapping, and requalification as required. - Monitor quality performance metrics, trends, and risks; communicate results and recommendations to site and regional leadership. - Drive continuous improvement initiatives to enhance quality performance, compliance, and operational efficiency. - Ensure quality training programs, competency requirements, and qualification records are established and maintained. - Partner cross-functionally with Operations, Engineering, IT, and Customer teams to ensure compliant and scalable solutions. - Other duties as assigned. **Required Qualifications & Experience:** - Bachelor's degree in Quality, Engineering, Life Sciences, Food Science, or a related field. - 8 years of experience in quality, compliance, manufacturing, distribution, or regulated operations. - 4 years of experience in a Quality leadership or management role. - Demonstrated experience leading and maintaining Quality Management Systems. - Experience working in regulated environments and interacting with auditors and customers. - Formal training or certification in Lean, Six Sigma, or quality risk management methodologies; Internal candidates to demonstrate QDM proficiency with QDM Expert certification. **Preferred** **Qualifications & Experience**: - Experience in regulated environments such as medical devices, pharmaceuticals, healthcare logistics, or food distribution. - Working knowledge of ISO-based quality systems (e.g., ISO 13485, ISO 9001), GMP, GDP, HACCP, FSMA, or similar regulatory frameworks. - Experience planning and executing equipment and systems validation activities, including WMS, environmental monitoring systems, and material handling equipment. - Hands-on experience conducting and maintaining warehouse temperature mapping studies and ongoing monitoring programs. - Experience supporting new customer onboarding, facility expansions, or major process…