| Description: | REQUIREMENTS
Bachelor’s degree in a scientific or technical field, preferably in the biological sciences. An
advanced degree is preferred.
10 years of GMP related experience in pharmaceutical, biologics, medical device, or related industry, along with knowledge of applicable US and foreign regulations. At least 4 years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience. Focused experience with GMP computerized systems and 5+ years of experience with auditing/inspection activities.
• Excellent knowledge of regulatory requirements including 21 CFR Part 11, Annex
11, PIC/s guidelines and other cGMPs.
• Ability to express views and opinions, listens well and accept conflicting points of
view. Experience leading cross functional teams.
• Strong written and oral communication skills, excellent presentation and influencing skills
• Effective technical/business communication skills and ability to interact and influence
different levels of management, locally and globally. Proven ability to work with diverse
environments and cultures globally.
• Strong experience with risk strategies, harmonized solutions and industry standards for
business processes.
• Experience with application of electronic records and signatures, GAMP, global
regulatory compliance and SDLC, with extensive experience in interfacing with regulatory
Email resume in Word to JeffAltman@TheBigGameHunter.us. Please include the job code for the position with your resume. NOTE: WE WILL ONLY RESPOND IF YOUR RESUME APPEARS TO FIT A ROLE
NO RELOCATION. NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.
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