Vacancy expired!
Hi, We have an urgent job opening with our Direct client. Please go through the job description and let me know the following information: -Interest and good fit for the position (Y/N): - Availability: - Visa status: - Best Contact number: - Best hourly pay rate expectation: - Please attach updated resume in word format. Title: Management/Professional Location: Boulder, Colorado, United States,80301 Duration: 18+ months For local candidates onsite 2 days a week Job Profile: Accountable for the Quality management of external suppliers' products, processes and related documents to determine if product requirements are met and for ensuring that quality systems are maintained. Through regular oversight and audits, monitors quality activities and systems at supplier and subcontractor facilities. May administer a certified supplier program. May also perform due diligence and vendor selection. May perform deviation investigations into quality issues. Role Summary: The Global External Quality Operations Mission is "to be a proactive partner, driving a science and riskbased compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives." External Supply Quality (ESQ) is committed to supporting the program as an innovative and competitive advantage by assuring the quality of products manufactured and packaged by other companies (Contractors). ESQ is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally. Role Responsibilities: The ESQ Manager/ CQL is accountable for providing quality assurance management of key contractors and assuring that the products supplied to our patients are manufactured, tested in accordance with cGMPs, 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 program. (S)he will operate as spokesperson for ESQ and will spend a significant period of time developing relationships, independently negotiating, developing and communicating quality requirements with contract manufacturers. The ESQ 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 ESQ BASIC QUALIFICATIONS Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting At least 4 years of Product Quality Assurance experience in a GMP environment Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms Strong verbal and written communication including presentation skills 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 PREFERRED QUALIFICATIONS Experience with external suppliers/contractors is preferred Experience with aseptic/ biotech manufacturing is preferred 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. Regards, Mary Celestina Lead Recruiter Email: mary@infobahnsw.com US # +1 530-214-0068 2010 N. 1st Street, Ste 470, San Jose, CA 95131 www.infobahnsw.com
Vacancy expired!