Director Global Quality Management System

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Quality 

 

Summary:

 

The Director, Global Quality Management System (QMS) is responsible for developing, implementing and sustaining a harmonized, world-class QMS across the organization.  This role ensures global processes and systems are compliant with all applicable regulatory requirements and supports operational excellence across all sites. This role leads the enterprise-wide strategy to develop integrated & automated Quality Management System processes. 

 

This role is responsible for the management and monitoring of the following QMS key processes: CAPA, Non-Conformances, Document Control, QMS related Training, Enterprise Wide QMS software solutions, Internal Audits, Global Management Reviews, QMS metrics and trending etc.

 

Hollister Incorporated operates in a hybrid work environment.  For this position, we require the Associate to be onsite a minimum of 3 days per week.

 

Responsibilities:

 

• Ensures processes and systems within responsibility are compliant with all external and internal requirements.
• Ensures Quality Plans are developed and maintained when appropriate to drive implementation and/execution of initiatives while maintaining the effectiveness of the Quality Management System
• Responsible for early signal to management regarding concerns related to Global QMS.
• Drives QMS standardization/harmonization across sites as appropriate
• Works closely with site QMS/QA leads to ensure inputs and feedback on global QMS processes and systems is included to ensure smooth transition and implementation of actions per defined plans.
• Oversees the governance standardization and continuous improvement of key QMS processes.
• Collaborates with sites and regional stakeholders to ensure clear and proactive
• communication of changes for an effective change control.
• Identifies KPIs, tracks and monitors QMS performance metrics to identify trends and drive actions for continued improvements.
• Provides oversight and visibility of the performance of Hollister QMS
• Responsible for identifying systemic concerns and ensures appropriate investigation and action to address root cause as appropriate
• Shares lessons learned, near misses and best practices across sites for the areas of responsibility
• Leads readiness for regulatory inspections and ensure appropriate support for sites as needed.
• Responsible for identifying and maintaining global owners for global QMS policies and procedures including establishing responsibilities for these owners.
• Develops and communicate Quality Management enterprise-wide strategy, define budget requirements and resources
• Defines and implements performance metrics ensuring alignment with GQM strategy
• Leads, understands, champions and implements new regulations and guidelines to ensure compliance with applicable regulatory requirements and standards.
• Acts as a Corporate GQM Management Representative
• Responsible for implementing and maintaining an effective internal audit program for all Hollister sites within scope.
• Responsible for defining the risk management process for Quality Management System (not product related) to ensure issues are managed and prioritized accordingly.
• Defines plans and actions to drive high engagement within the team
• Responsible for effective talent management, development and succession planning for the area of responsibility.

 

Essential Function of the Role:

 

Communication/Leadership:

 

• Management of Talent Development and Employee Engagement
• Budget Management
• Strategic Planning and Deployment
• Ability to interface with a computer for a long period of time
• Public speaking requirements
• Significant reading requirements
• Constant utilization of listening skills, both person to person and over the phone
• Sitting for prolonged periods
• Talking
• Ability to travel domestically and internationally
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