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

Requirements:

• 12-15 years overall 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 and 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.

Education Requirements:

• Bachelor's degree 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)
  • ASQ Certified Quality Auditor (CQA)
  
  
  
  

Specialized Skills/Technical Knowledge:

• Hands on experience ensuring compliance with: Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, CFR 21 FDA 820, MDD/MDR etc.) is required.
• Extensive experience working in Medical Devices.
• Experience with statistical sampling plans based on risk management.
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies required.
• Knowledge of ERP Systems preferred.
• Strong in Microsoft Office suite, especially Excel.
• Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
• Working knowledge of continuous improvement and root cause problem solving in medical device.
• Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
• Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies.
• Good interpersonal skills with the ability to work as part of a cross functional team.
• Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner.
• Fiscal Management
• Have a continuous improvement mindset and demonstrated change management skills.
• Fully fluent in English, verbal and written

#LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $160,000 - $230,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34885