Quality Compliance Manager

1 week ago


Sanford, Florida, United States ECLARO Full time
Job Title: Quality Compliance Manager

Job Summary:

We are seeking a highly skilled Quality Compliance Manager to lead our site's quality compliance efforts. The successful candidate will have a strong background in GMP compliance and experience in managing quality systems.

Key Responsibilities:

  • Coach and mentor site personnel on 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 GMPs and CP Global Quality Standards.
  • Responsible for daily documentation authorizing product release and the execution of release procedures.
  • Interpret and communicate regulatory policies and requirements to CP personnel.
  • Supervise and manage plant documentation systems, including SOPs, Management of Change, Notices of Deviation, Batch Records, Nonconformances, and Validations.
  • Supervise consumer complaint trends and history, ensuring all returned samples and adverse event complaints are fully investigated and documented.
  • Manage the Site Annual Product Review and provide necessary compliance documentation and corrective action strategies for continuous improvement.
  • Ensure that designs, specifications, implementation, and maintenance of a cGMP system follow 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, specifically with paperless initiatives.
  • Empower team members through training, information sharing, mentorship, feedback, and delegation.

Required Qualifications:

  • 5+ years' work experience in a manufacturing plant operating in a Food or Drug/GMP environment.
  • Comprehensive knowledge of site-wide documentation systems, Product Release, and Batch Record review.
  • Familiarity with and ability to implement GMP-compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation.
  • Knowledge of Change Control Systems and FDA regulations.
  • Leadership skills.
  • First-hand experience managing or supporting regulatory inspections.
  • Experience with SAP QM, LIMS, or similar integrated computerized systems.

Preferred Qualifications:

  • Supervisory experience.
  • 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 the 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 is highly desired.

Experience with the utilization of statistical tools (e.g., MiniTab) is desired.



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