Dendreon Corporation

Quality Assurance Manager

General Summary:

The Quality Assurance Manager will provide direct support to Seattle Manufacturing, Contract Manufacturing, and Supply Operations activities associated with the manufacturing and control of cGMP raw materials, components, and product as described below.

Principal Duties and Responsibilities:

• Supervise Quality Assurance staff and budget.
• Review and Approval of GMP Controlled Documents including SOPs, Batch Records, and Test Methods.
• Disposition of Raw Materials, Components, and Product.
• Management of the Material Review Board.
• Review and Approval of Deviations and CAPAs.
• Tracking and Trending of Quality Systems including Deviation, Non-Conformance, and CAPA.
• Development and generation of the Annual Product Review.
• Management of the recall for non conforming materials.
• Management of investigations associated with Product Complaints.
• Initiation of Biological Product Deviation Reports.
• Provide training on cGMPs and Quality Systems.

Job Specifications and Requirements:

• Bachelors degree in science, engineering or equivalent experience with a minimum of 10 years experience in quality assurance, quality control, or compliance for commercial pharmaceutical or biotechnology derived parental and/or cellular therapies preferred.
• Knowledge of cGMP/QSR and FDA device/drug/biologics regulations is required.
• Prior management experience.
• Individual should have attention to detail and excellent written & oral communications skills.
• Strong computer skills with Word, Excel, and Access are required.

Working Conditions and Physical Requirements:

• Physical requirements include ability to operate a personal computer, automated office equipment, and to work at a desk for long periods of time with frequent opportunity to move to other locations within the building.

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.

Dendreon Corporation

Dendreon Corporation is an Equal Opportunity Employer

Submitted: 03/06/2006