Seattle Genetics

R&D Quality Specialist

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 R&D Quality Specialist will support operations and infrastructure projects of the Research & Development Quality (RDQ) group. RDQ is the Quality Assurance group responsible for oversight of GCP, GLP and GVP with the Development organization at Seattle Genetics. In this new position you will play a key role in compiling, trending and reporting key quality metrics to Senior Management. You will support audit management activities within the department and be actively involved in development and administration of core infrastructure systems. This position will also support inspection preparation and management activities. The R&D Quality Specialist will work directly with the Manager, RDQ Operations to ensure that company/department goals and objectives are met and compliance risks are identified, mitigated, and communicated to senior management.

The applicant will have a unique opportunity to develop metrics and processes in trending of issues and compiling data that will be presented to Senior and Executive Management for mitigation of risks in clinical and non-clinical studies. In addition, they will have a key role in identifying areas of growth within RDQ and increase efficiencies regarding day to day activities and regulatory agency inspection preparation activities.

Responsibilities:

• Support audit management activities within the Research & Development Quality department including tracking all audits and outcomes, audit response tracking and follow-up, contracts and requisition for contract auditors and management of audit related documents and information.
• Review audit reports, deviations and CAPAs and collate metrics to analyze trends and conduct risk assessments. Analyze data to help generate Quality Performance Indicators (QPIs) and Key Performance Indicators (KPIs) that will be presented to Executive Management.
• Participate in development and administration of projects needed to support activities of RDQ:
• Audit Management System.
• Track status of GCP/GLP/GVP specific Deviations, Planned Deviations and CAPAs in the Quality Management System and assist with follow-up, documentation and close out of records in a timely manner.
• Provide support in the logistics, coordination and management of regulatory inspections (FDA, EMA, MHRA, etc).
• May assist with the logistics, organization and presentation material for the Quarterly Quality Council and Bimonthly Quality Forum meetings.

Qualifications:

• BA/BS degree and a minimum of 5 years’ experience in the pharmaceutical/biotechnology industry, with at least 3 years of clinical trial/GCP/quality assurance experience Experience with clinical trial monitoring (GCP, GLP or GVP) and/or auditing preferred Experience with identifying and/or implementing Audit Management systems (i.e. Trackwise, Veeva) Demonstrated knowledge and understanding of Essential Documents, CFR and GCP/ICH Detail-oriented, with good organizational, time management and project management skills Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment and ready to embrace a culture of flexibility and innovation Proficiency in MS Word, Excel, PowerPoint, MS Project, Adobe, and database applications.

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.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/23/2019