Manager, Quality GXP Compliance - Trainer

Manager, Quality GXP Compliance - Trainer
Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

Currently, we have a great opportunity for a highly motivated team leader to manage the cGMP compliance training aspects of the Amylin Quality System.

Specifically, you will:

• Manage the design, development and delivery of comprehensive cGMP training courses for newly hired and experienced employees in Amylin internal cGMP functions
• Provide training course effectiveness review material for assessment purposes
• Collaborate with the Learning and Development department to maximize the use of available technology and resources for training course development
• Develop content for cGMP compliance training presentations
• Write clear, compelling, and accurate training material
• Provide new employee and on-going training to personnel on cGMP regulations, Quality systems and compliance topics
• Remain current on proposed regulations and regulatory enforcement trends to apply as sources for training opportunities
• Create and design instructional presentations using tools provided by the Training and Development department
• Deliver compliance training to GXP personnel
• Determine training presentation roll-out strategies and timelines
• Coordinate area-specific training content with appropriate departmental SMEs
• Assist in other GXP Compliance group responsibilities (e.g., regulatory inspections, procedure revisions, compliance improvement initiatives)


Requirements
This position requires:

• A BA/BS with at least 8 years experience in the pharmaceutical industry and with cGMP compliance regulations
• At least 5 years of experience developing and/or delivering compliance instruction
• Thorough knowledge of FDA and regulatory requirements
• Excellent written/verbal communication skills
• PC proficiency with MS Office
• Demonstrated experience in GXP compliant quality systems is preferred.
• Experience in instructional design and working in a rapid-growth environment is desired.

By “Challenging Science,� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.



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AMYLIN

Challenging Science. Changing Lives.