Director Global Quality Management System

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 validation, Internal Audits, Global Management Reviews, QMS metrics and trending etc.

• ◆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

for these owners.

• ◆Develops and communicate Quality Management enterprise-wide strategy, define budget

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

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.

• ◆Communicate effectively via email, phone, and virtual platforms.
• ◆Collaborate across departments to support organizational goals.
• ◆Participate in cross-functional meetings and initiatives.
• ◆Prepare reports and dashboards for internal stakeholders.
• ◆Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• ◆Ensure data accuracy and confidentiality in compliance with company and legal standards.
• ◆Manage multiple priorities and deadlines in a fast-paced environment.
• ◆Lead or support special projects aligned with departmental objectives.
• ◆Demonstrate initiative in identifying process improvements or automation opportunities.
• ◆Serve as a point of contact for internal and external stakeholders.
• ◆Resolve inquiries and issues with professionalism and discretion.
• ◆Provide guidance on policies, procedures, and benefits (where applicable).
• ◆Adhere to company policies, including those related to ADA, data privacy, and ethics.
• ◆Maintain secure handling of sensitive information.
• ◆Support audits and regulatory reporting as needed.
• ◆Vision-setting and alignment with business strategy.
• ◆High-level decision-making and resource allocation.
• ◆Oversight of compliance, risk, and organizational culture.

• ✓Bachelor’s Degree with 12-15 years of related experience

• ✓Minimum of 5 years of experience in medical device environment. Direct or hands on experience managing and implementing Quality Management Systems, CAPAs, Nonconformances, Internal Audit programs and Quality Management System Software and Validation. Direct experience managing external audits (Notify Body) and Inspections (FDA). Knowledge, Experience managing and driving continuous improvement, identifying Key Performance Indicators and trending. Management experience driving talent and performance with direct and indirect reports. Experience in global, role matrix organization.
• ✓Understanding of US and International Quality Systems regulations, including FDA cGMP and ISO 13485 and ISO 14971 Risk Management standards is required.

MBA or MS preferred.

Any or all of the following professional society certifications are desired, but not required:

ASQ Certified Manager (CQM)

ASQ Certified Quality Engineer (CQE)

ASQ Certified Reliability Engineer (CRE)

(ISO 13485, ISO 14971, CFR 21 FDA 820, MDD/MDR etc.) is required.

• ✓Extensive experience working in Medical Device