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Manager, Non Sterile-External Quality
Ref No.: 18-06491
Location: Princeton, New Jersey
Position Type:Full Time/Contract
Start Date / End Date: 09/03/2018 to 03/01/2019
• Experience in developing and managing client/vendor relationships from development through end of relationship.
• Required knowledge of manufacturing operations; including API manufacturing, environmental monitoring, drug product manufacturing, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing.
• Experience leading cross-functional project teams.
• Ability to troubleshoot manufacturing process deviations and analytical OOS results as needed.
Experience dealing with external supply world, contract manfacturing
Product knowledge of Non Steril Products- tablets, capsules, ointments/creams etc

Skills & Competencies:
• 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.
• Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
• Understands quality by design principles and how to define critical process parameters.
• Can conduct FMEA to assess risk and identify risk mitigation actions.
• Review statistical analysis that measures process capability and trending performance.
• Experience in negotiation/influencing and management of remote third party partners.
• Ability to supervise work and task completion of associates or interns.
• Ability to work independently on complex problems and issues and determine acceptable solutions and approaches.
• Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases.
• Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing.