Seattle Genetics, Inc.

Clinical Quality Assurance Manager

This CQA Manager position will assume responsibility and oversight for assessing and managing clinical quality assurance and compliance with GCP.

Responsibilities include:

• Serve as the primary Quality and Compliance advisor for the Clinical team.
• Conducting audits and managing contracted audits.
• Identify, manage and follow up on required CAPA and continuous improvement efforts.
• Develop and manage the GCP training program.
• Development and implementation of additional quality systems necessary to assure clinical team compliance with GCP’s, regulatory requirements, industry and company standards.
• Resource planning and workload management.

This position will manage and oversee the integration of Seattle Genetics quality operations with various contract research and contract service organization providing GLP or GCP services.

This successful candidate will play a key role in representing the department internally on integrated project teams and acting as a primary contact externally at various Contract Manufacturing and Research Organizations. Quality issues and key findings will be presented to senior management. Other responsibilities will include auditing, reviewing clinical trails master files and other essential documentation.

Requirements:

• BS Degree in Science, Nursing or equivalent.
• A minimum of 8+ years working in a Clinical, QA or Regulatory environment.
• Experience working in biopharmaceutical development is preferred.
• A thorough knowledge of GLP’s, GCP’s, ICH and other regulations applicable to U.S. and international regulatory agencies and the appropriate application to clinical and non-clinical studies.
• Must be capable of interpreting and applying regulatory requirements as appropriate to assure quality using sound judgment and decision-making skills.
• Excellent written and oral communication skills.

When applying for this position, please refer to posting #CS06-01 and let us know how you heard about the opening.

Seattle Genetics is an equal opportunity employer. We strive to find ways to attract, develop and retain highly qualified individuals representing the diverse communities in which we live. For more information on opportunities at Seattle Genetics, please visit us at www.seattlegenetics.com.

Seattle Genetics, Inc.
Reference Job Code: CS06-01
Attn: Human Resources
21823 30th Dr. SE
Bothell, WA 98021
Fax: 425-527-4109
Email: hr@seagen.com

Seattle Genetics, Inc. is an Equal Opportunity Employer

Submitted: 02/15/2006