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Global Validation Manager

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Date: Sep 12, 2022

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Quality 

Summary:

 

The Validation Manager has responsibility for the validated state of all equipment and manufacturing systems at Hollister Incorporated. The position has oversight on the introduction and maintenance of all equipment, process validation and computer systems utilized to support GMP manufacturing. Reporting to the Director of Quality Management, this role is responsible for management of all process equipment and computer system validation, testing documentation, development and execution of protocols, and strategic planning for compliant computerized operations in a GMP environment. This role also supports the administration and maintenance of the Quality document control process globally. 

 

This role will support the establishment of standard work practices and testing for the qualification and ongoing maintenance of equipment and computerized systems at Hollister Incorporated. The Validation manager will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state of equipment. The role will own the annual Periodic Review and Requalification plans for all equipment and manufacturing systems at Hollister Incorporated. The validation manager will work cross functionally with project teams and manufacturing facilities to ensure compliance with global and local procedures, standards, and regulations with regards to validation and documentation controls.  The validation manager will maintain proficiency on standards, regulations, guidance documents to provide continuing awareness on changing requirements and ensure compliance.  Hollister Incorporated operations in a hybrid work environment.   Individual can be based out of any Hollister factility.

 

Responsibilities:

 

  • Owner of the Global validation program for Hollister Incorporated, including global procedures and SOPs to ensure they are in compliance with applicable regulations and guidance documents (EU/FDA/MDSAP).
  • Act as Validation SME providing guidance, direction and lead validation activities across all departments and helps drive best practices to support GMP manufacturing.
  • Owner of the Global validation program for Hollister Incorporated, including global procedures and SOPs to ensure they are in compliance with applicable regulations and guidance documents (EU/FDA/MDSAP).
  • Act as Validation SME providing guidance, direction and lead validation activities across all departments and helps drive best practices to support GMP manufacturing.
  • Develop and advise on the continuous improvement of Hollister’s Validation program and procedures ensuring a risk-based approach is employed.
  • Provide leadership in change management and risk assessment for Validation including communication to key stakeholders for alignment.
  • Lead and manage cross-functional software remediation project across manufacturing sites.
  • Provide assessment of changing standards, regulations, and guidance documents, and identifies any needed changes to internal policies, processes, or practice to develop software/process validation processes/procedures and continually improve upon them.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation
  • Writes software validation protocols for the Libertyville applications and provide support to the manufacturing sites and corporate team in writing and reviewing local protocols as applicable.
  • Acts as dotted line supervisor to quality engineers based at the manufacturing sites.
  • Promotes staff development, helping identify areas of development focus and action plans
  • Advise and review project team testing requirements, test plans, and test scripts.
  • Monitor test results and collaborate with business analysts and business team members to determine corrective actions.
  • Represent validation team at both internal and external audits and at Quality System Management Reviews.
  • Leads activities related to computer system validation in preparation and during internal and external audits, which includes support to responses, remediation, and readiness.
  • Mentor and guide the internal/external assigned team to facilitate completion of validation activities.
  • Identify and qualify all computer systems that affect cGMP operations using a risk-based methodology.
  • Responsible for the overall administration of the document control program related to process and software validation.

 

Requirements:

 

  • 8-12 years overall experience is required
  • Bachelor’s Degree in a scientific or engineering discipline required, Advanced Degree desired
  • Experience working with computer systems software development and validations, or related field is essential, regulated environment, medical devices experience is preferred. Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11).
  • Previous people management (direct or indirect) experience preferable 
  • Strong awareness and understanding of the medical device quality and regulatory requirements, including ISO13485, IEC62304, 21CFRpart 820, part 11 as well as CSV processes
  • Demonstrated working knowledge and effective implementation of applicable software validation requirements
  • Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation.
  • Strong overall knowledge with IT infrastructure and applications
  • Working knowledge of Software Development Life Cycle (SDLC) of medical device software
  • Strong oral, written communication, and interpersonal skills.
  • Experience of Testing GAMP Category 3, 4 & 5 systems. (Process Validation) - highly desired.
  • Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
  • Strong leadership skills with the ability to influence change and develop people
  • Goal-oriented with the ability to execute on strategic initiatives and prioritize/manage deliverables
  • Excellent technical abilities with a solid base in engineering.
  • Demonstrated interest in, and understanding of, industry developments and trends
  • Good project management skills including organization and planning.
  • Able to work in a global and matrix environment
  • Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
  • Strong critical thinking skills applying and cultivating new approaches to problem solving with a focus on achievement of overall project goals
  • Experience interacting with auditors
  • Ability to work independently and remotely with minimum direct supervision
  • Ability to travel internationally 20-30% 
  • Must be able to speak/write in English

 

#LI-Hybrid

 

Our Total Rewards package in aggregate is above market and includes competitive pay, generous paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

 

Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it 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 (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability


Job Req ID: 30777


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