Senior Director of Quality Systems & Compliance

Job Summary

Responsible for overseeing and directing strategic planning for large and highly complex Quality teams; ensuring quality and compliance for applicable products and processes for assigned departments. Job Description

MAJOR RESPONSIBILITIES

* Provide leadership and expertise in the development of strategy for the applicable organizations; motivate and engage others around team vision and manage others to ensure execution. * Direct and lead the teams in the development of product specifications for all Medline branded products. * Provide assistance, support and expertise to Suppliers, manufacturing partners and product manager developing and implementing QA programs. * Advises leadership to ensure the QSR for assigned departments are in compliance as measured by FDA/ISO/internal audits. * Act as liaison with Executive Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction. * Design, implement, and oversee the Pharmaceutical Quality System (PQS) across the organization. * Own and govern key quality system processes, including CAPA, Document Control, Change Control, Management Review, Field Alert Reporting, and Recall Management. * Ensure effective and timely CAPA execution across the Pharmaceutical Quality Organization (PQO) and serve as the organization's CAPA subject matter expert. * Ensure proper reporting, investigation, escalation, and closure of Field Alert Reports in accordance with regulatory requirements. * Establish and maintain an effective training program to ensure personnel competency and compliance across PQO. * Partner with Medline Corporate and Division Quality leaders to ensure complaint handling processes effectively support pharmaceutical operations and regulatory requirements. Management responsibilities include:

* Typically, manage through multiple Managers. Provide leadership and management to one or more major departments of an opera