Overview

Job Summary Oversee and lead Quality Assurance functions for Manufacturing Quality, Sourcing Quality, and Sterility Controls. Provide enterprise-level strategic direction and operational leadership to ensure effective quality controls, compliance with applicable regulatory requirements, and alignment across manufacturing, supplier, sourcing, and sterility-related processes. Lead teams responsible for supplier quality controls, manufacturing quality systems, sterilization, process validation, pFMEA, DMR requirements, and related production and supply-chain quality controls. Job Description MAJOR RESPONSIBILITIES Oversee, lead, and set strategic direction for Manufacturing Quality, Sourcing Quality, and Sterility Controls. Lead related Corporate Quality activities in partnership with manufacturing, sourcing, supplier quality, and divisional leaders to assure adherence to US FDA, EU MDR, and other applicable requirements. Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies. Lead quality activities that support manufacturing operations and sourcing processes, facilitating effective communication between Quality Assurance leaders, manufacturing teams, sourcing partners, suppliers, and divisional personnel to support business objectives and ensure quality requirements are met. Direct quality efforts for supplier qualification, sourcing controls, manufacturing quality activities, sterilization, process validation, pFMEA, DMR requirements, and production quality controls. Assure appropriate communication between related functions and ensure project timelines, objectives, escalation pathways, and compliance requirements are met. Provide leadership for Manufacturing Quality and Sterility Controls, including oversight of sterilization, process validation, pFMEA, DMR activities, and associated quality systems to ensure effective controls and compliance with applicable requirements. Develop training programs, approve process and procedural changes. Ensure proper systems are in place to facilitate a smooth and efficient process for new products and services. Oversee that all internal and external customers receive outstanding service from QA department. Management Responsibility Lead, organize, plan, direct, staff, coordinate, and communicate across the QA management team and staff responsible for Manufacturing Quality, Sourcing Quality, and Sterility Controls to execute the business plan and operational changes needed to meet company-specific goals. Provide guidance and direction to subordinate leaders, including setting performance standards and monitoring performance. MINIMUM JOB REQUIREMENTS Education Typically requires a Bachelor's degree in a business-related field or related experience in medical device, OTC pharmaceutical or cosmetic manufacturing Work Experience At least 15 years of QA related experience in a regulated business environment (i.e., Medical Device, OTC drugs, Cosmetics) At least 10 years of progressively responsible people-leadership experience, including hiring, developing, motivating, directing, and holding leaders and teams accountable for performance, organizational effectiveness, and succession planning. At least 5 years of senior executive-level experience, at the Vice President level or above, leading a multi-site quality organization with responsibility for cross-functional execution, organizational capability, and enterprise-level quality outcomes. Knowledge / Skills / Abilities Willing to travel up to 50% of the time for business purposes (within state and out of state and international). Strong knowledge of Quality Assurance practices in regulated industry (Device, Pharma, Personal Care or Food). Leadership skills for leading an organization and coordinating resources, policies and employees. Experien