Quality Manager, External Manufacturing

Responsible for performing all key quality activities necessary to support external manufacturing activities in the GBU. Activities will include external manufacturer selection, start-up, problem remediation, ensuring compliance to cGMP requirements, and support of ongoing manufacturing. ESSENTIAL FUNCTIONS:1. Participate in the establishment of minimum standards for compliance, processes, systems, personnel, and procedure for External Manufacturers (EM)2. Conduct approval audits to ensure a potential EM is capable of meeting Covidien quality standards3. Monitor EM performance to quality requirements, including cGMP compliance, on a scheduled basis4. Establish systems for review and approval of documentation, including batch documentation, validation protocols and reports, and failure/exception investigations5. Monitor EM performance and capability by on-site monitoring, such as during process validation studies or for routine manufacturing, as needed6. Establish routine metrics of performance for the EM and communicate performance to Covidien and EM management7. Establish routine monitoring of quality datastreams for potential initiation of Corrective/Preventive Actions (CAPA)8. Provide final Covidien approval for product disposition, as directed by manager9. Provide ongoing support for cGMP enhancement, FDA inspection readiness, and remediation of issues noted either before or as a result of such inspections10. Establish, monitor, and approve Quality Agreements, as delegated by manager11. Serve as the Covidien representative regarding potential product/process changes proposed by EM12. Serve as the Covidien representative and resource regarding regulatory filings13. Serve as a member of the Covidien EM team regarding team activities, functions, and proposals14. Work with members of the Covidien EM team to ensure that overall requirements, schedules, and objectives are achieved15. Serve as a resource/representative of the Director, Quality to other Pharmaceutical GBU plants, as assigned16. All other duties as assignedRequirements: Education required/ preferred: B.S. degree in Chemistry/Biology, Engineering, or related fieldExperience: A minimum of 8 years experience in the pharmaceutical industry. Familiar with cGMP regulations, preferably serving as direct host or resource during site FDA or EU inspections Preferred Skills/Qualifications: Thorough understanding of FDA and cGMP guidelines; Analytical and problem solving skills; technical writing; conflict resolution skills; computer literate Skills/Competencies: Must be able to demonstrate the following: Professional knowledge in job related techniques, show initiative, communicate effectively (written and oral), plan and organize.Other Skills: Skilled in the use of statistical techniques as applied to vendor, process and product quality control. Requires understanding of marketing, accounting, financial and business management principles.ORGANIZATIONAL RELATIONSHIPS/SCOPE: Reports to Director, QualityTo apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.