Sr Manager - Quality Testing

Manage key product and stability testing groups and compliance activities to achieve site and corporate objectives. Provide overall Quality Control (QC) leadership regarding (current Good Manufacturing Practices) cGMP compliance concerns and improvement for the Generics Business.

Requirements

• Ensure key turnaround timelines for customer service and compliance requirements are achieved
• Manage stability testing to achieve 100% on-time analysis for all stability protocol testing intervals
• Serve as the primary liaison for method transfers into the QC organization
• Provide overall leadership to QC groups regarding cGMP compliance improvement and enhancement
• Serve as the Subject Matter Expert during compliance audits
• Study and improve various Quality processes through increased efficiency or process flow using Lean Manufacturing and/or Six Sigma philosophy of operation
• Drive Quality consistency through revising or combining various analytical methods to ensure adequacy and quality with special emphasis on actual utility of methods under normal QC conditions
• Work with all Quality managers, supervisors and analysts to address any laboratory concerns regarding safety, methods, procedures, or operation
• Act as a liaison between the labs and manufacturing/R&D in implementing special projects, production campaigns, or assist with validations or method transfers
• Works with various reports and QC groups to ensure compliance to Environmental Health and Safety and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in our laboratories
• Ensure compliance with and oversee compendia affairs for SpecGx