ICOS Corporation

Director, Quality Assurance

Location(s): Seattle, WA

Company Overview

ICOS Corporation, based in Bothell, Washington, has spent more than a decade building a world-class research and development organization. Our first product, Cialisr, an oral PDE5 inhibitor for the treatment of erectile dysfunction is now launched in over 50 countries. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.

Responsibilities

The Director of Quality Assurance is responsible for development of quality assurance strategies, systems and processes to ensure that the Company's drug development, registration and commercialization plans meet federal, foreign, and company requirements, and enable the effective advancement of product candidates from clinical stage through product marketing. The Director of Quality Assurance manages the QA and Document Control departments at ICOS responsible for cGMP and GLP compliance.

• Establish requirements in quality standards, systems, processes and standard operating procedures, and ensure that operating actions meet requirements as defined by the federal and foreign statutes.
• Develop and manage budgets and resources and actively promote teamwork and accountability.
• Develop plans, policies and procedures to ensure compliance to GMP regulations, Corporate Quality/Compliance policies, procedures and goals, and appropriate quality assurance standards governing filing of IND, NDA.
• Identify and manage efforts to ensure that quality needs are addressed in the contract manufacture of R&D; products.
• Identify criteria and process to review and disposition manufactured product lots (API and drug products).
• Develop and manage a system to qualify and audit CROs and testing laboratories for GMP and GLP compliance.
• Establish key quality metrics and develop collection, analysis and reporting system which promotes timely communication and correction action.
• Lead cross-functional teams within the company and/or outside (i.e., Joint Ventures) to address quality/compliance needs.
• Establish policies and procedures to provide QAU support for in-house GLP studies.

Requirements

• Bachelors and/or Masters Degree in a relevant scientific discipline.
• Extensive knowledge and working experience with all aspects of quality assurance which relate to pharmaceutical development and clinical research.
• Minimum of 15 + years of directly relevant experience in managing quality/regulatory compliance functions in a pharmaceutical development organization. This must include at least five years in a senior level position.
• Excellent interpersonal skills including the ability to collaborate effectively with cross disciplinary project teams.
• Superior oral and written communication skills.
• Proven ability to manage a variety of tasks with attention to detail and to build consensus in problem solving and decision making.
• Demonstrated skill in analyzing and developing solutions to complex problems relating to pharmaceutical development.

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 or email kfenstermacher@icos.com highlighting the position in the subject line.

Learn more about ICOS' philosophies, attributes, financial information, and more by visiting our web site at:

ICOS Corporation
Reference Job Code: 1648SH0404
Karen Fenstermacher

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 05/07/2004