Quality Compliance Manager

1 day ago

Sanford, United States ECLARO Full time

Quality Compliance Supervisor Lead

DIRECT HIRE

The salary will be updated later - The rate posted is sample rate only


Responsibilities Include:

  • coaches and mentors site personnel in regard 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 (local resident expert and leader for compliance and related GMP concerns).
  • Supervision and management of plant Documentation system (This includes all documents vital to an FDA inspection- SOP's, Management of Change, Notices of Deviation, Batch Records, Non conformances, and Validations)
  • Supervise Consumer Complaint trends and history. Ensures that 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 the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards
  • Supervision and management of site's Management of Change (MOC) program.
  • Supervision and management of 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, mentor, 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 system, Product Release, and Batch record review.
  • Must be familiar with and able 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 is also an expectation of this position.
  • 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 is highly desired.

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

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