Sr. Manager, Quality Management Systems

At Church & Dwight, we value talented professionals with a strong desire to make a positive impact in our company. As a rapidly growing organization, we are always seeking passionate and creative individuals whose action-oriented mindset will foster continued growth throughout our leading brands.

Role Summary:                                                          

  • This position is responsible for the Quality Management System implementation at assigned site(s), ensuring compliance with FDA regulations, ISO 13485, MDSAP and other applicable standards/regulation

Responsibilities:                                                     

  • Support the implementation and maintenance of an innovative Global Quality Management System (QMS) and associated infrastructure that is compliant, effective, efficient and agile. Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth.
  • Establish, implement and maintain Quality Management Systems to meet FDA 21CFR820, ISO13485, MDSAP, and other regulatory requirements as applicable. Systems include (but not limited to): Change Management; Document and Record Control; NCR; CAPA; Complaints; Validation; Audits; Training.
  • Own the respective QMS architecture and processes
  • Continually improve the respective QMS element
  • Manage the global CAPA processes.
  • Provide support for the Quality Management Reviews and Global Quality Council Metrics.
  • Ensure Document Controls.
  • Provide M&A Due Diligence and Integration support
  • Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives
  • Establish, review and maintain department procedures and policies
  • Provide guidance, support, motivation, and coaching for effective communication, critical thinking, teamwork, and department flexibility.
  • Review and/or directly respond to matters of escalation needing management level attention.

Requirements:                                                         

  • Education: Minimum of Bachelor’s degree from accredited institution (Quality Assurance preferred)
  • Experience: Ten years experience in the Quality Assurance with a minimum of 4 years in a managerial role, preferably with a medical device company.

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/.

Apply at: https://churchdwight.wd1.myworkdayjobs.com/en-US/chdcareers/job/Princeton-NJ/Sr-Manager–Quality-Management-Systems_R2019-504