Sr Dir Field Corrective Actions

Sr Dir Field Corrective Actions# Medline Careers## Sr Dir Field Corrective ActionsApply: Remote: Northfield, Illinois: Full time: Posted Today: R2622112**Job Summary**The Senior Director, Field Corrective Actions provides enterprise leadership and strategic direction for the global processes used to evaluate, decide, plan, execute, monitor, and close field corrective actions across diverse business divisions, product portfolios, and regulatory jurisdictions. The Senior Director is accountable for the performance and results of the corporate Field Corrective Action function and associated teams, ensuring actions involving distributed product are risk-based, timely, effective, traceable, and compliant with applicable international regulatory requirements and internal quality system procedures. The role provides leadership through Directors and/or Senior Managers; establishes enterprise governance, decision rights, escalation pathways, performance expectations, and resource priorities; and adapts and executes functional strategies to achieve key patient-safety, regulatory, quality, and business objectives. Decisions made by the role strongly impact the corporate department and Medline business segments. The Senior Director serves as a principal liaison with the U.S. Food and Drug Administration and other regulatory authorities and advises executive, divisional, and functional leaders on significant field action risk, strategy, commitments, and business implications.**Job Description**# **MAJOR RESPONSIBILITIES*** Provide enterprise leadership and strategic direction for the global Field Corrective Action function through Directors and/or Senior Managers and multidisciplinary professional teams.* Account for the performance and results of diverse Field Corrective Action and supporting operational teams across business divisions, product portfolios, including medical devices, pharmaceuticals, cosmetics, food products, and human tissue products, and regulatory jurisdictions.* Adapt and execute enterprise and functional strategies to achieve key patient-safety, regulatory, quality, and business objectives; establish long-range priorities and operating plans for the function.* Establish and maintain enterprise governance, decision rights, escalation criteria, performance measures, and standardized processes for corrections, removals, recalls, and related actions involving distributed medical devices, pharmaceutical products, cosmetics, food products, and human cells, tissues, and cellular and tissue-based products.* Provide executive oversight of voluntary and mandatory field corrective actions, including containment, affected-product definition, consignee identification, action scope, communications, regulatory reporting, effectiveness checks, reconciliation, and closure.* Ensure documented assessment of whether corrections and removals are reportable under 21 CFR Part 806; and applicable requirements for pharmaceutical products, cosmetics, food products, and human tissue products; ensure timely submission of required reports and maintenance of records and rationale for non-reportable actions.* Chair or provide senior governance for Health Risk Assessments and other risk-based decision processes used to determine the need, scope, urgency, and strategy for field corrective actions.* Ensure production and post-production information is evaluated and linked to applicable risk management files, including new hazards, changes in estimated risk, risk acceptability, benefit-risk conclusions, and effectiveness of risk controls.* Ensure identified risks drive appropriate enterprise action through complaint handling, adverse event reporting, CAPA, design or formulation, manufacturing, labeling, servicing, training, supplier controls, donor eligibility or tissue controls, food safety controls, and other applicable quality system processes.* Approve high-impact or complex field corrective action strategies, including geographic scope, regulatory and customer communications, product disposition, correction methodology, and effectiveness-check plans.* Ensure enterprise product, lot, batch, serial, distribution, consignee, and donor or tissue traceability capabilities, as applicable, support accurate and timely identification of affected products, customers, consignees, locations, and other required records.* Serve as a senior company liaison with FDA and other regulatory authorities regarding reportability, notifications, classification, action strategy, execution status, effectiveness, inspection readiness, and closure for medical devices, pharmaceuticals, cosmetics, food products, and human tissue products.* Direct portfolio-level oversight of action progress, response rates, product reconciliation, effectiveness-check results, exceptions, overdue activities, and objective evidence supporting closure or termination.* Lead enterprise inspection and audit readiness and anticipate regulatory and standards developments affecting recalls, corrections, removals, market withdrawals, food safety actions, human tissue actions, post-production risk information, and lifecycle risk management.* Advise and influence executive, divisional, and functional leaders; secure resources, resolve enterprise conflicts, assign accountable owners, and maintain execution across divisions and geographic regions.* Provide executive and governance-body reporting on field action status, regulatory commitments, aggregate risk, effectiveness, aging, resource constraints, systemic issues, and emerging trends.* Direct organizational design, workforce and succession planning, leadership development, performance management, capability building, resource investment, and budget management for the function.* Sponsor enterprise improvements, technology enablement, analytics, and standardized operating models that strengthen field action decision quality, speed, traceability, effectiveness, and inspection readiness across all covered product categories.# **MINIMUM JOB REQUIREMENTS****Education*** A bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.**Work Experience*** The position requires at least 8 years of experience in medical device, pharmaceutical, biologic, cosmetics, food product, human tissue, or other regulated healthcare or consumer-product quality systems, including at least 5 years of management-level experience.* Experience must include leadership through Directors and/or Senior Managers and accountability for a global or multi-divisional corporate function.* Demonstrated experience overseeing complex recalls, corrections, removals, market withdrawals, stock recoveries, or other field corrective actions involving distributed regulated products is required.* Relevant experience should include product-specific reportability assessments, regulatory submissions and notifications, health hazard or product risk evaluations, customer and consignee communications, lot or batch traceability, effectiveness checks, reconciliation, disposition, closure, regulatory inspections, and health-authority interaction.**Knowledge / Skills / Abilities*** Demonstrated ability to lead through Directors and/or Senior Managers and drive performance across diverse departments, divisions, geographic regions, and regulated product categories.* Ability to adapt and execute functional strategies, establish enterprise governance, deploy resources, and make decisions that strongly impact a business segment or corporate department.* Advanced knowledge of FDA and global Field Corrective Action requirements applicable to medical devices, pharmaceutical products, cosmetics, food products, and human cells, tissues, and cellular and tissue-based products, including relevant quality, risk management, adverse event, traceability, recall, correction, removal, market withdrawal, and regulatory communication requirements.* Ability to establish defensible, product-specific decision frameworks for reportability, classification, scope, urgency, communications, effectiveness, disposition, and closure.* Executive-level communication, negotiation, and influence skills, with the ability to align senior leaders across Quality, Regulatory Affairs, Medical Affairs, Research and Development, Manufacturing, Supply Chain, Legal, Commercial, Food Safety, Tissue Operations, and divisional leadership. Proficiency in Microsoft Office applications and data analysis tools.* Position requires travel up to 20% for business purposes globally.# **PREFERRED JOB REQUIREMENTS****Education*** An advanced degree in a relevant scientific, engineering, healthcare, regulatory, or business discipline and experience.**Certification / Licensure*** Professional certification in quality, regulatory affairs, risk management, or organizational excellence.**Work Experience*** 15 years of progressive experience in regulated healthcare or consumer-product quality, post-market surveillance, food safety, tissue compliance, or regulatory operations, including substantial experience leading globally distributed leaders and teams responsible for recalls, corrections, removals, market withdrawals, regulatory authority communications, inspections, or notified body audits.* Preferred experience includes accountability across multiple regulated product categories, such as medical devices, pharmaceuticals, cosmetics, food products, and human cells, tissues, and cellular and tissue-based products, as well as diverse departments, divisions, product portfolios, and jurisdictions.* Additional beneficial experience includes risk management, design or formulation controls, manufacturing controls, validation, supplier controls, donor eligibility and tissue traceability, food safety controls, clinical or patient risk assessment, quality system records, enterprise traceability, and technology-enabled Field Corrective Action management.**Knowledge / Skills / Abilities*** Demonstrated success translating organizational and functional strategies into global operating models, long-range plans, and measurable business outcomes across multiple regulated product categories.* Ability to advise executive leadership, lead significant health-authority interactions, and direct responses to regulatory inspections and audits involving medical devices, pharmaceuticals, cosmetics, food products, human tissue products, and Field Corrective Actions.* Strong enterprise judgment, strategic thinking, and decision-making capability in matters with substantial patient-safety, consumer-safety, regulatory, reputational, operational, and financial implications.* Proven ability to lead organizational change, develop Directors and Senior Managers, build succession depth, optimize resource investments, and promote a culture of safety, quality, accountability, and continuous improvement.Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.The anticipated salary range for this position:$203,000.00 - $305,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. #J-18808-Ljbffr