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Global Quality CAPA 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:                                                           

The Global CAPA Lead is responsible for ensuring that Church & Dwight’s global event management system, including non-conformances, deviations/concessions and CAPA globally meet all applicable corporate and regulatory requirements.  He/she will collaborate with all sites to ensure local CAPA process is in conformance and root cause investigations, containment, corrective actions and effectiveness checks are in place. This will be done by supporting local CAPA Boards around the globe.   He/she will ensure training and coaching is available to all CAPA site captains.  The Global CAPA Lead is responsible for identifying trends across sites, ensure same-in-kind CAPAs are implemented at all applicable global sites.  This role reports out to the functional Vice Presidents the status of all sites and manages the Corporate CAPA Board, as well as has responsibility for the Event Management metrics at the Global Corporate Quality Management Review

Responsibilities:                                                

  • Ensure CAPAs are written in accordance with the companies & Notified Body & GMP standards; throughout the Provider's engagement while adhering to the companies and cGMP standards
  • Implement necessary follow-up verification checks on investigation Corrective and Preventive Action items, ensure timely follow-up and approval occur throughout term of the CAPA process.
  • Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done; must respond timely to deliver quality investigations and thorough CAPAs throughout the term of the project.
  • Coach Company colleagues facilitate a focused knowledge transfer regarding quality investigations regularly throughout the term of project.
  • Review Company's SOPs related to the quality investigational system and assist with improvement/revisions in a timely manner throughout term of project.
  • Attend any investigational related meetings as required
  • Ensure PQM number of licenses is adequate and used as needed
  • Train new users and super users (SME Role)
  • Coach Company colleagues to facilitate a focused knowledge on Medical Device CAPA terminology and process as described in 21CFR820.100, ISO13485, and MDSAP   in accordance with C&D’s QEP and SOP
  • Review Company's SOPs related to the quality investigational system and assist with improvement/revisions
  • Responsible for reviewing, analysis of trends and reporting of quality performance to senior management via Quality Management Review (QMR)
  • Work with Quality partners in development of metrics and prepare QMR
  • Assist in execution of containment, investigation, root cause, action, and verification of effectiveness write-up and approvals for Quality System CAPAs on a timely basis; understand interaction between quality systems
  • Development of CAPA verification of effectiveness with applying sampling statistical rationale
  • Retrospective reviews of quality records as part of remediation
  • Ensure compliance of CAPA program
  • Schedule and lead the Corporate CAPA Board
  • Support local CAPA Boards
  • Ensure PQM number of licenses is adequate and used as needed

Requirements: 

                                                    

Education:

Minimum of bachelor’s degree in a science or mathematics field from an accredited institution.

Experience:

3- 5 years of experience in Medical Device / CAPA process per 21CFR820.100 and ISO13485

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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