Global Quality Change Management Lead
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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)
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.
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