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,…