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Global Quality Validation 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 Validation Lead will oversee the Corporate Validation Program at a functional level. Most importantly, this individual will establish and oversee the corporate validation program while providing subject matter guidance, for all equipment, utility, production processes and laboratory GxP equipment systems, including computerized systems and data integrity.

Owning the Validation Program of the corporation as it relates to regulated products and critical systems, the incumbent will work closely with functional operations and/or engineering leads, ensuring activities involving the selection of equipment/systems, commissioning, qualification, and/or validation of systems and processes are performed in compliance to standards and GxP requirements applicable to Church & Dwight Co.

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

  • Enhance, oversee, and maintain the overall C&D Validation program, including C&D Policy, Global procedures and templates.
  • Provide leadership in Validation to ensure that C&D sites meet the regulatory expectations for cGMP manufacture of products and are aligned with industry expectations.
  • Set direction and provide leadership in the areas of process validation, cleaning validation, equipment qualification, laboratory systems validation, and all other aspects of the Validation Program.
  • Oversee, assess, approve, and generate validation documentation including validation master plans, User Specific Requirements, determination of CSV and associated electronic records regulations applicability, plans, protocols, execution and reports.
  • Management of validation life cycle to ensure ongoing validated state through oversight of the execution of validation studies for processes, cleaning, systems and equipment qualification as required.
  • Managerial responsibilities include team development through coaching and training with the objective to have a cross-functional group that works well in a cross-functional environment.
  • Set strategic and technical goals for the Validation program, providing continuous improvement in the areas of cleaning validation, equipment qualification, and process validation.
  • Provide direction and set goals to ensure compliance with all aspects of the Quality Management System for Validation ensuring a state of inspection readiness.
  • Serve as the lead for Validation during regulatory inspections.
  • Support validation team defining validation strategy and approaches assuring validation initiatives are performed with scientific and statistical justification (as applicable).
  • Serves as the validation SME for review/approval of deliverables associated with equipment systems and processes. This includes the URS, tech transfer, qualification, validation and revalidation activities.
  • Ensure that there is adequate rationale defined for the closure of generated non-conformances, discrepancies and deviations associated with qualification/validation execution efforts.
  • Performs risk assessments related to validated state of equipment, systems and processes.
  • Performs duties related to Quality Management Systems, as assigned.

Education and Experience                                                          

  • B.Sc./M.Sc. degree in relevant Science or Engineering from accredited institution in related field
  • Minimum of ten (10) years’ experience in Commissioning, Qualification and/or Validation functions
  • Experience with implementing and overseeing validation programs in a commercial manufacturing plant.  
  • Expertise in GxP compliance in consumer products, medical device, and/or pharmaceutical industries
  • 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 in Risk Management
  • Demonstrated ability to work cross-functionally, to develop and maintain strong partner relationships
  • Strong analytical and problem-solving skills and critical thinking abilities
  • 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 prioritize, be proactive, meet deadlines, and be a team player
  • Ability to work independently with minimal supervision
  • Good verbal and written communication and presentation skills

#piq
#acc

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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DIVERSITY At Church & Dwight

Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.

We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.

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CULTURE At Church & Dwight

We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.

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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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