QA Manager

QA Manager
Reference #: MON-04074
Ohio Manufacturing Facility


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, hands-on professional to manage and support Change Control, Auditing, CAPAs, Batch Disposition, Deviations, Out-of-Specifications (OOS) and other relevant compliance activities for Bulk Processing, Filling, Inspection and Packaging Operations.

Specifically, you will:

• Prepare the annual product review and regulatory inspections
• Review data obtained during all quality activities to ensure consistency with company policies, procedures and specifications
• Keep management team abreast of significant issues or developments identified during quality activities, as well as actions being taken for improvements
• Develop and implement quality improvement program and ensure management and employee quality responsibilities are met
• Trend and analyze data from Quality Systems to ensure the review of relevant metrics
• Participate in the established review cycle of QA controlled documents to assure practices reflect written procedures
• Provide guidance and audit overview to the responsible parties for appropriate corrective/preventive action and due dates
• Prepare and present technical and quality system program information to management
• Develop strategies and programs for the improvement of productivity and efficiency of the various quality system processes
• Prepare the Quality department budget
• Facilitate employee teams to build cohesiveness and improve the overall results of the respective teams’ tasks
• Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GMP regulations
• Formulate and maintain quality system objectives complementary to corporate policies and goals

This position requires:

• A BA/BS in science or engineering with 8+ years of experience in the sterile injectables pharmaceutical industry with an emphasis on cGMP quality systems management
• A sound understanding and working knowledge of current GMP regulations
• PC proficiency with MS Office, MS Project, and Electronic Document Management System
• Excellent written/verbal communication skills.

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.