Seattle Genetics

Manager/Senior Manager GMP Document Control and Records Management

Description

Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) uses the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.

Beyond ADCETRIS®, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer use our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.

Summary

The Manager/Sr. Manager of Document Management provides leadership over the GMP Document Control and Records Management groups at Seattle Genetics. The position will lead the GMP Quality and functional areas in the development and deployment of a new document hierarchy to support the global growth of Seattle Genetics. The position will oversee all day to day activities for the group, as well as represent Quality Systems and Document Management in cross-functional teams to ensure and communicate quality requirements as they relate to Quality Systems.

The position will report to the Director of Quality Systems and play a key role in advancing the Document Management function to support a global biopharmaceutical company.

Responsibilities:

• Management oversight of the GMP Document Control and Records Management functions, including the records file rooms, and the electronic document management and records management systems.
• Develop, revise, and refine the GMP Document hierarchy supporting GMP activities within a growing global biopharmaceutical company.
• Provide day to day management of staff, including setting of assignments, tracking of deliverables, establishing quality goals in alignment with corporate goals, and setting staff development objectives.
• Acts as business process owner of GMP Quality electronic systems including but not limited to electronic Document Management System and electronic Records Archive System.
• Supports computer system validations for owned electronic applications.
• Establishes, maintains, trends, and reports on leading and lagging metrics related to area of responsibility.
• Establishes relationships with key personnel in GMP functions to ensure collaboration, foster cooperation, and ensure positive outcomes.
• Contributes to the creation and revision of cross-functional policies and procedures ensuring compliance with applicable regulatory requirements, guidances, and industry best practices
• Works with leaders and staff of GMP functional areas to ensure new or revised policies and procedures are in alignment with company policies and document control hierarchy requirements.
• Provide regulatory inspection support.
• Represent Document Management during regulatory inspections, third party/partner audits, and Seattle Genetics internal audits.
• Review and approve Change Controls, Deviations, and CAPA related to area of responsibility.
• Applies knowledge of appropriate compliance requirements including ICH guidance, global Health Authority requirements, and industry best practices to guide the development and evolution of the GMP Document Control and Records Management function.
• Within cross-functional teams, participates on projects impacting multiple GMP locations or areas within a site.
• Actively seeks out and applies continuous improvements to functional area of responsibility and supported functional areas.

Requirements:

• Requires a minimum of 12+ years’ experience in pharmaceuticals or biopharmaceuticals, and at least 3 years of experience in people management.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Working knowledge of cGMP is required, including ability to understand and apply regulations, guidances and industry best practices to area of responsibility.
• Detail oriented with strong organizational, time, and project management skills.
• Strong written and verbal communication skills.

Education:

• A minimum of a bachelor’s degree.

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.

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Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 10/25/2019