GXP Compliance Manager AMLN-01830

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in our corporate office in San Diego, CA:

 

GXP Compliance Manager

(AMLN-1830)

Reporting to the Senior Manager of GXP Compliance, manage the maintenance of the overall Amylin Quality System comprised of cGMP, GLP and GCP quality system components. Manage the development and/or enhancement of the Amylin internal Quality Compliance team, comprised of approximately two to four team members. Oversee and participate in the generation, review and/or revision of written procedures to support GXP activities. Assist in the management and the establishment of Quality-related activities in support of both internal and external operations.

 

Requires a B.S. degree required, science degree preferred with at least eight (8) years experience in the pharmaceutical industry with a minimum of five (5) years direct experience developing, implementing, and managing GXP Quality Systems. Experience with interacting with third parties (e.g., contract service providers) is preferred. Knowledgeable in FDA expectations is essential. Direct experience developing, implementing and managing comprehensive GXP compliant quality systems is highly desirable. Managerial experience is required. Excellent communication skills including: technical writing skills, PC skills, and good questioning and analysis techniques desired. Additional necessary characteristics include: being a self-starter, goal oriented, attention to detail, team-oriented, and ability to multi-task.

 

Amylin offers competitive compensation, benefits and stock options. Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at www.amylin.com. AA/EEO Employer.