Overview

Job Summary Responsible for providing leadership and direction to the Sustaining Quality organization to ensure quality and compliance for commercial products and associated Quality Management System processes. Develop strategy, translate priorities into functional plans, and guide execution of long-term remediation, product lifecycle quality, and systemic improvement goals. Job Description MAJOR RESPONSIBILITIES Develop and implement the strategy, operating model, priorities, and governance for Sustaining Quality in alignment with Quality objectives, regulatory commitments, and business needs. Lead complex, cross-functional remediation and product lifecycle quality programs. Establish risk-based portfolio management and execution controls to prioritize work, assign resources, monitor milestones, manage dependencies, and escalate patient safety, compliance, product availability, and business continuity risks. Identify systemic process, governance, and ownership gaps revealed through remediation, CAPAs, complaints, risk assessments, field actions, and audits; partner with process owners to implement sustainable improvements and prevent recurrence. Act as liaison with senior leadership, Divisional Quality, Corporate Quality, Regulatory Affairs, Research and Development, Product Management, Manufacturing, Operations, and other functions to drive alignment, decisions, and execution. Oversee inspection and audit readiness for assigned programs and ensure supporting records and objective evidence are complete, accurate, traceable, and compliant with applicable requirements. Develop and maintain performance measures and executive reporting for remediation progress, quality-system backlog, CAPA effectiveness, risk, resource capacity, and program performance. Lead, develop, and allocate internal and contract resources to support changing regulatory, technical, and business priorities while building sustainable organizational capability. Management responsibilities include: Typically manages through multiple Managers. Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability. Strategic, tactical, and operational planning for the function or department extending 12 months or longer. Direct budgetary responsibility for one or more departments, functions, or major projects/programs. Interpret and execute organizational policies and recommend new policies or modifications to existing policies. Hiring staff, recommending pay increases, performing performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies. MINIMUM JOB REQUIREMENTS Education Bachelor's degree in Engineering, Science, Quality, Regulatory Affairs, or a related technical field. Work Experience At least 7 years of experience in medical device, pharmaceutical, drug combination product, or another regulated industry, including experience with quality systems, design controls, risk management, CAPA, remediation, or post-market quality activities. At least 4 years of management experience. Knowledge / Skills / Abilities Depth of technical knowledge of relevant standards and regulations, including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and MDR. Proficiency in analyzing and reporting data to identify issues, trends, or exceptions, drive improvement, and support risk-based decision-making. Demonstrated ability to lead complex, cross-functional programs; control concurrent projects and competing priorities; and meet critical deadlines. Demonstrated ability to identify systemic issues, translate requirements into sustainable processes, and influence decisions across organizational boundaries. Advanced communication skills with the ability to present complex quality, regulatory, and business matters to senior and executive leadership. Advanced proficiency in Microsoft Excel a