Quality Compliance Manager

4 weeks ago

Sanford, United States Colgate-Palmolive Full time
Job Summary

Colgate-Palmolive is seeking a Quality Compliance Supervisor to join our team. This role will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities
  • Direct conformance to GMP/Quality standards and establish a culture to enable the site to deliver consistent, safe, and effective products.
  • Maintain a comprehensive site documentation system, author and maintain the site Validation Master Plan, and ensure site-wide compliance to 21 CFR Parts 11, 210, 211, and 820.
  • Coach and mentor site personnel in regards to Compliance issues.
  • Lead/participate in consumer/customer satisfaction improvement initiatives.
  • Support the development, implementation, and monitoring of the manufacturing site Quality Plan to ensure compliance with both GMP's and CP Global Quality Standards.
  • Responsible for daily documentation authorizing product release and the execution of release procedure.
  • Interpret and communicate regulatory policies and requirements to CP personnel.
  • Supervise and manage plant Documentation system.
  • Supervise Consumer Complaint trends and history.
  • Manage the Site Annual Product Review and provide necessary compliance documentation and corrective action strategies for continuous improvement.
  • Ensure that the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards.
  • Supervise and manage site's Management of Change (MOC) program.
  • Supervise and manage FDA Drug Listings and international drug registrations.
  • Contribute to the local Automation, Digitization and Analytics (ADA) strategy; in specific with the paperless initiatives.
  • Ensures the development of people, teams, and organizational capabilities by empowering team members through training, information sharing, coaching, feedback, and delegation.
Requirements
  • Bachelor's Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering, or a related field.
  • 5+ years work experience in a manufacturing plant operating in a Food or Drug / GMP environment.
  • Extensive knowledge of site wide documentation system, Product Release, and Batch record review.
  • Must be familiar with and able to execute GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation.
  • Knowledge of Change Control Systems and FDA regulations.
  • First-hand experience managing or supporting regulatory inspections.
  • Experience with SAP QM, LIMS or similar integrated computerized systems.
Preferred Qualifications
  • Supervisory experience.
  • Leadership skills to move to higher management position.
  • Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS, and Global Materials, Logistics & Sourcing Departments, as well as material/component suppliers.
  • 2 years of experience preparing documentation for Product Registration in country of sale.
  • 2 years of experience managing Consumer Complaints.
  • 2 years of experience completing Product Release documentation and final approval.
  • Experience in hosting/leading an FDA inspection.
  • Experience with utilization of statistical tools (e.g. MiniTab).

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