Quality Manager - Katalyst Healthcares & Life Sciences

• Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
• Ability to work independently on problems and issues and determine acceptable solutions and approaches
• Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
• Understands quality by design principles and how to define critical process parameters.
• Can conduct FMEA to assess risk and identify risk mitigation actions
• Complete Annual Product Quality Reports (APQR)
• Review statistical analysis that measures process capability and trending performance.
• Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
• Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing

Requirements:

• Experience managing client/vendor relationships
• Required knowledge of manufacturing/packaging operations; including environmental monitoring, drug product manufacturing/packaging, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing
• Experience supporting cross-functional project teams
• Experience dealing with external supply world, contract manufacturing
• Product knowledge of Non Sterile Products- tablets, capsules, ointments/creams, etc.
• Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.
• Strong Communication Skills both oral and written- Savy in electronic systems as well
• Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.
• Requires excellent verbal/written communication, negotiation/influencing, leadership and risk assessment skills.
• Experience in negotiation/influencing and management of remote third party partners
• Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases
• B.S. Degree in Engineering or Science or equivalent with a minimum of 5 years pharmaceutical industry experience (may include Operational/Quality/Compliance/Validation experience in pharmaceutical industry).
• Experience in managing client/vendor relationships
• Required knowledge of manufacturing/packaging operations in the pharmaceutical industry
• Experience supporting cross-functional project teams