Dendreon Corporation

IT Compliance & Validation Manager

Dendreon Corporation (Nasdaq: DNDN) is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp.

We are seeking an IT Compliance & Validation Manager to oversee the systems compliance and validation efforts for GMP, 21CFR Part 11, Sarbanes-oxley, HIPAA, and other related regulations. This position will manage an IT Compliance Specialist and will work closely with individuals in the Quality Department.

Description:

• Ensure computer systems comply with all GMP and 21CFR Part 11 requirements.
• Ensure computer systems comply with all other related regulations such as Sarbanes-Oxley and HIPAA.
• Understand and comply with all related internal Standard Operating Procedures.
• Understand and document user and functional system requirements.
• Develop system validation plans.
• Ensure the proper development of technical, configuration, and design specifications.
• Draft and review qualification protocols and coordinate IQ/OQ/PQ testing.
• Prepare qualification, validation, and trace matrix reports.

Requirements:

• 4+ years experience in GMP computer systems validation.
• 2+ years experience managing personnel.
• Prior experience with Sarbanes-Oxley and HIPAA systems compliance.
• Bachelor’s degree in related field or equivalent experience.
• Prior biotech or pharmaceutical industry experience.
• Solid knowledge of desktop, server, applications, and network basics.
• Strong communication skills and team orientation.

The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. Please visit www.resourcehire.com/clients/Dendreon/publicjobs/controller.cfm to submit your resume.

Dendreon Corporation
Reference Job Code: 4871

Dendreon Corporation is an Equal Opportunity Employer

Submitted: 03/06/2006