Quality Compliance Manager
1 week ago
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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