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Global Quality Change Management Lead

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

         

Role Summary                                                          

Reporting to the Head of Global Compliance & QMS, the Global Quality Change Management Lead will oversee the Change Management Program at a functional level. Most importantly, this individual will be responsible for the governance, oversight, global alignment, design, maintenance and execution of the change control process and system in compliance to applicable standards and GxP requirements applicable to Church & Dwight Co., and lead the Change Control Board process.

The incumbent directs the Change Management Program of the corporation, ensuring that all changes are assessed for impact, have appropriate actions that are not conflictual with existing C&D Policies, GSOPs, GxPs or applicable standards/regulations of the domestic and international regulatory authorities.

Role Accountabilities and Responsibilities   (Describe the 5-7 major accountabilities)                                                       

  • Enhance, oversee, and maintain the overall C&D Change Management program related to pre-commercial and commercial manufacturing operations, ensuring compliance with current applicable regulations and standards in a consistent manner globally.
  • Owner of the Change Management process and system design for the Corporation:
    • Participates in the design, implementation, and training on the Change Management e-QMS system (Agile PLM enhancement)  
    • Is a Change Analyst and Super User in Agile PLM
  • Responsible for oversight of the day-to-day execution of the change management process controlling the lifecycle of all production changes to enable beneficial changes to be made in a consistent, controlled manner.
  • Represent Quality Agile PLM meetings as the single quality point of contact (SQPOC) for Princeton Location.
  • Lead and facilitate the Change Control Review Board discussions to ensure decisions are made in a timely manner with the cross functional team with appropriate subject matters experts (SMEs). Ensure all critical functions (Operations, Quality, Regulatory, R&D, etc.) are present and actively participating and regulatory (US/other markets), qualified persons (QP) representing other countries and other relevant assessments are included for all GxP changes.
  • Ensure changes are effectively communicated to impacted functions and processed timely throughout the network.
  • Ensure Change controls are impact assessed, reviewed, and approved by appropriate subject matters experts (SMEs) and implemented as prescribed per the change scope.
  • Works with Change owners to progress robust changes through system.
  • Assure actions do not conflict with existing procedures, GMPs or applicable regulations.
  • Establish, monitor, and report metrics (KPIs) related to the change management program for the Corporation. Distributes monthly metrics reports (written and graphic) to plant management and Quality Leadership team regarding the status of changes and their sources.
  • Managerial responsibilities include team coaching through hands-on guidance and personnel training for those performing activities within the change control quality system, including, action implementations, etc.
  • Provide direction and set goals to ensure compliance with all aspects of the Quality Management System for Change Management, ensuring a state of inspection readiness.
  • Support internal and external audits and inspections:
    • Act as SME, present the change management program established for C & D;
    • Is a member of the audit teams, supports backroom;
    • Participates in preparatory activities and contribute to observation responses.
  • Performs duties related to Quality Management Systems, as assigned.

Education and Experience                                                           

  • B.Sc./M.Sc. degree in Science from an accredited institution in related field
  • Minimum of ten (10) years’ experience in Quality or regulatory compliance in consumer products, medical device, and/or pharmaceutical industries
  • Experience in establishing and maintaining a change control process including developing change implementation plans, determining change control requirements, and ensuring all changes are implemented in a manner to control risk to the organization
  • Experience with QMS, e-QMS and validated software

Skills and Competencies

  • Strong knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.)
  • Strong knowledge of regulations governing medical device, pharmaceutical products, Cosmetics, Food, and consumer goods (cGMPs, ISO 13485, MDD/MDR, etc.)
  • Continuous improvement mindset, detailed oriented and organized
  • Ability to communicate clearly in an engaging manner with colleagues of various levels of experience and management
  • Ability to work independently with minimal supervision
  • Ability to prioritize, be proactive, meet deadlines, and be a team player
  • Good communication and presentation skills
  • Competent using Microsoft suite and statistical software (i.e. MiniTab)

#piq
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COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.

*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ

Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/


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Role Location

United States

With corporate offices and major plants across the country, we’re building consumer products and connecting with global offices from the place where it all began.

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C&D 500X500 035

Equal Employment Opportunity for the Disabled At Church & Dwight

As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to jobs@churchdwight.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to jobs@churchdwight.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.

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