This position is responsible for developing, implementing and maintaining regulated Quality Systems for the manufacturing and logistics facilities to ensure compliance with FDA and customer requirements. The Quality Systems Manager will work closely with Quality Assurance Operations, Quality Control Laboratory and Manufacturing Operations departments to develop quality systems, process and procedures that ensure proper regulatory compliance is maintained throughout all facilities.
Job Accountabilities and Essential Functions:
• Develop and manage Deviation Investigation and CAPA processes.
• Manage Customer Complaint process including trending, reporting, and investigations.
• Manage Internal Auditing program including training, system development, and metrics.
• Manage Annual Product Reviews and Quarterly Management Review processes.
• Manage Product Release Program including batch record review process, metrics, customer CoAs.
• Manage Document Control program including change control and metrics.
• Key participant in regulatory inspections and customer and 3rd party audits.
Required for Position:
• Minimum Bachelors Degree in Engineering, Chemistry, Biology/Microbiology, or other related science discipline.
• Experience in pharmaceutical or medical device quality assurance systems in manufacturing, minimum 7 years with 3 or more in leadership or supervisory role.
• Experience in root cause analysis, risk analysis methods, leading investigations.
• ASQ or RAPS certifications preferred, especially Auditor, Biomedical Auditor, or Pharmaceutical GMP
Please send your resume to the following email address: email@example.com