ICOS Corporation

Manager, Quality Assurance (External Compliance)

The successful candidate will be responsible for planning, scheduling and performing GMP compliance audits of third party manufacturers, contract laboratories, contract service providers, and key suppliers. The individual will also be responsible for representing QA on new chemical entity product development teams, including authorizing change control requests and reviewing production records for projects and facilities represented, performing data integrity audits of regulatory submissions, and providing consistent quality and compliance advice to project development teams. Additional responsibilities include supervising personnel and developing or modifying internal SOPs governing the audit program as needed.

This position requires a Bachelor’s degree, 5+ plus years of experience in a quality role (pharmaceutical experience preferred), including experience with product development and GMP compliance audits. Experience with Quality Assurance/GMP Compliance in early and late phase clinical trial manufacturing and contract manufacturing (either as a supplier or customer) is preferred. This position requires a working knowledge of pharmaceutical Good Manufacturing Practices with an emphasis on new chemical entity manufacturing, an understanding of basic scientific principles, and a sound understanding of quality systems. Computer literacy is required. This position requires the ability to travel both domestically and internationally.

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

For immediate consideration visit www.icos.com and apply directly for this position.

Learn more about ICOS’ philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com.

ICOS Corporation
Reference Job Code: 1187

ICOS Corporation is an Equal Opportunity Employer

Submitted: 04/11/2003