Description
Description QA Manager:The Global Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."
Contract Operations Quality Assurance (COQA) is committed to supporting our clients' Global Supply as an innovative and competitive advantage for our client by assuring the quality of products manufactured and packaged by other companies (Contractors) for our client.
COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.
Responsibilities QA Manager:
The COQA Manager is accountable for providing quality assurance management of key contractors for our client and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within our client. (S)he will operate as spokesperson for COQA and will spend a significant period of time developing relationships, independently negotiating, developing and communicating our client quality requirements with contract manufacturers. The COQA Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtually based cross functional teams. S(he) will report to the Director/Team Leader COQA.
Technical skills QA Manager:
• Minimally BA/BS Science, Engineering, or related technical discipline with at least 8 years in a GXP setting
• At least 4 years of Product Quality Assurance experience in a GMP environment
• Experience with external suppliers/contractors is preferred
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
• Command of English language required and multi-lingual is beneficial.
• Strong verbal and written communication including presentation skills
• Up to 30 % travel required
Personal skills QA Manager:
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers
• Demonstrated ability to manage multiple projects
• Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader
• Has excellent organization skills
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
• Developing personal leadership to manage cross functional projects
• Developing ability to resolve conflicts
• Takes initiatives and is proactive, persistent
• Has a broad GMP and technical know-how to handle emerging issues