Manager, Quality Document Management System and Compliance

Summary:

The Manager will be responsible for the deployment, administration, and management of the GCP/GLP/GVP quality document management system at Seattle Genetics, Inc. The Manager will author, review, approve and manage Directives, Policies, Standard Operating Procedure, and other related GCP/GLP/GVP documents in support of the Quality Manual. They will ensure that the quality systems are compliant with regulatory requirements and company policies and business needs. The Manager will represent Research and Development Quality (RDQ) in project teams and ensure the communication and understanding of quality requirements and expectations as relates to quality systems. The incumbent will work directly with the Associate Director, Standards and Training RDQ to ensure that company goals and objectives are met and that compliance risks are identified, mitigated, and communicated to senior management.

Responsibilities:

• Lead the development, deployment, and management of the GCP/GLP/GVP quality document management system
• Develop, author, review, contribute and approve Directives, Policies and SOPs in support of the Quality Systems Manual and other functional areas
• Development and implement Quality Metrics related to the Quality document systems
• Develop, conduct and maintain Employee quality document orientation and Quality Refresher Training
• Conduct internal compliance audits
• Participate in the development of Regulatory Authority inspection strategies
• Represent Research and Development Quality in cross-functional Program Teams
• Effectively communicate progress and issue resolution to the Associate Director, Standards and Training RDQ and key stakeholder of the Program Teams

Qualifications:

• A minimum of 7 years of QA GCP/GLP experience in biotech/pharmaceutical environment
• Experience with Learning Management Systems (LMS) and Document Management Systems (QDM)
• Demonstrated success managing quality systems such as, deviations, change controls, etc.
• Demonstrated knowledge and understanding of quality compliance principals with specific focus on GCP/GLP

Education:

• A Bachelor's degree or higher

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.