Quality Compliance Manager
3 hours ago
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.
- 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.
- 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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