Quality - Compliance Manager

kdc/one Port Jervis, 20 West King Street, Port Jervis, New York, United States of America Req #2076
Thursday, August 25, 2022
KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products. KDC delivers high-touch innovation, operational excellence, and speed to market to well-known and emerging beauty, personal, and specialty companies from coast to coast. KDC has its head office in Longueuil, Québec. In addition, KDC has 10 operating facilities located throughout North America. Altogether, the company employs nearly 4,800 talented and dedicated employees in North America.

Title:   

Compliance Manager

Reports to:

Senior Director of Quality

Department:

Quality

Supervises:     

Validation Coordinator and Validation Technician

 

Organizational Relationships:

 

Interact with departmental leaders to ensure that all business operations are in line with the company procedures and regulations.

Basic Function:

 

  • Responsible for objectively measuring, trending, and identifying areas to improve the performance of the Quality system, internally and at external suppliers.

 

  • Assess compliance with kdc/one Quality policies and procedures through the company internal audit program, as well as oversight of the external audit certification programs.

 

  • Support the Supply and Customer Quality team by auditing external suppliers. Audit for compliance of paper and electronic master data, as well as perform more traditional GMP audits.

 

  • Ensuring kdc/one maintains compliance and best in class Quality Systems at the time the company transition from paper to more electronic systems, and act as the Quality SME.

 

  • Support and optimize site quality operations and practices through effective external audits, data analysis and coaching to ensure progress against any findings.

 

  • Support continuous improvement toward the goal of best in class quality systems through their interpersonal influence and coaching style.

 

  • Ensure compliance procedures are followed and updated as per regulations.

               

Responsibilities:

 

  1. Contributing to Team Success, actively participating as a member of a team to move the team toward the completion of goals.
  2. Preform various vendors internal and external program audits and reviews.
  3. Review vendor documentation to ensure required documentation is current and updated.
  4. Schedule and follow up the internal audits plan to ensure internal audits are performed on time, conduct monthly and follow up on status of observations and corrective actions.
  5. Conduct and coordinate facility audits as well as manage third party audits.  
  6. Maintain the company documentation such as, GMP, SOP’s, manuals, policies, and procedures as it relates to the OTC and Cosmetics products.
  7. Act as Recall Coordinator and perform annually Mock Recalls and Traceability.  Ensure Recall procedures are current and working properly.
  8. Review policies and procedures annually or as needed to ensure all policies and procedures are current to the standards set up the FDA, ISO 22716, and other governmental agencies.
  9. Update and review of existing procedures and documentation to keep up with changing regulatory standards and requirements.
  10. Oversight of the program to ensure validations, ADR and review of records are in compliance.
  11. Provide justification where timeframes for validation, review, and or reanalysis of exceed limits set out.
  12. Review vendor documentation to ensure required documentation is current and updated.
  13. Maintains the content of the QMS Manual and the structure: Quality Manual, Quality Policy, Procedures and Work instructions.
  14. Assure corrective measures are implemented and follow-up evaluations are completed to ensure effectiveness.
  15. Create Quality metrics to monitor and trend Quality throughout the organization.
  16. Reviewing departmental corrective action plans (CAPA) for accuracy and effectiveness.
  17. Participate and support the coordination of Management Review Meetings and action items.
  18. Identifies significant findings and provides recommendations to leadership.
  19. Educate Leadership on standards, principles, best practices of QMS; engage stakeholders to communicate QMS needs and coming changes.
  20. Review performance evaluation and development of direct reports, recommendations, and responses, and provides feedback.

 

  

Qualifications:  

  • Bachelor of Science in a related field, or equivalent.

  • A minimum of 5 years of Cosmetic and OTC experience, with management level experience in FDA, Validations and ADR is preferred.

  • Certifications and Comprehensive knowledge of ISO 22716 & 9001, GMP’s, and all regulations other regulations applicable to QMS for Cosmetics and OTC.

  • Detail oriented, and possess strong computer skills, including MS Office, PowerApps.

  • Bilingual English/Spanish preferred.

  • Strong ability to analyze and interpret general program instructions.

  • Have strong communication skills and proficiency in English reading and writing.

  • Able to develop and maintain relationships internally and externally.

  • Able to work unsupervised and manage independently.

  • Comfortable working in a fast-paced environment managing multiple/competing priorities.

  • Must be flexible with work hours and days.

  • Must be able to travel to company and vendor locations.

KDC-ONE is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, age, sex, gender, disability or any other characteristic protected by law. I understand that employment with KDC-ONE Company is at-will, meaning that I or KDC-ONE Company may terminate my employment at any time, or for any reason consistent with applicable state or federal law. I understand that KDC-One requires the successful completion of a drug and/or alcohol test as a condition of employment.

Other details

  • Pay Type Salary
  • Employment Indicator Indirect
Location on Google Maps
  • kdc/one Port Jervis, 20 West King Street, Port Jervis, New York, United States of America