Seattle Genetics

Director GLP Compliance

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

We are looking for a Director of GLP Compliance to support our drug development programs for transitioning drug candidates into early phase clinical studies. This position will report to the Senior Director, Research & Development Quality (RDQ). RDQ is responsible for Quality oversight of GLP, GCP, GPvP activities supporting ongoing and planned clinical trials, as well as clinical and non-clinical development laboratory activities.

The primary responsibility for this role is the strategic and operational lead for the GLP team. This position manages and directs the ongoing compliance and Quality Assurance activities to ensure pre-clinical, clinical, pharmacology, toxicokinetic and biomarker activities are performed in compliance with global GLP or other applicable regulatory requirements. This is a newly expanded leadership role within RDQ that will have an opportunity to continue to grow the existing GLP Quality Assurance Unit as well as actively participate in program teams and collaborate with other functional areas.

Responsibilities:

• Provide leadership and guidance for the continued development of GLP quality systems, including Standard Operating Procedures (SOPs), document management and personnel training.
• Lead process improvement and harmonization efforts, as appropriate to promote best practices regarding internal processes and procedures, biospecimen management and external vendor and lab qualifications.
• Provide quality oversight of contracting testing facilities and internal testing groups to ensure adherence to applicable requirements (regulatory and SOPs).
• Provide guidance to GLP auditors regarding quality issues and engaging cross-functional senior management support that require resolution.
• Analyze audit findings and report trends (and other quality metrics) on a periodic basis for reporting to Seattle Genetics Executive management.
• Review/approve and trend GLP deviations, planned deviations and CAPAs in Quality Management System.
• Participate in investigation of GLP deviations and assessment of appropriateness of proposed CAPAs.
• Ensure resources are available to execute compliance processes, mitigate compliance concerns and provide quality oversight.
• Provide operational input in the development of compliance including timelines, budget, and resource requirements.
• Point person to identify and communicate GLP quality and compliance risks to cross-functional working groups and participate in determination of appropriate plan for resolving the issues and addressing risks.
• Communicate activities and feedback to core management team.
• Review nonclinical sections of regulatory submissions (IND, BLA, NDA etc.) for accuracy, completeness, uniformity and compliance with regulatory requirements.
• Develop and/or provide input for the development of Annual Audit Schedule.
• Train/prepare employees for GLP and GCP regulatory inspections and provide leadership and guidance when applicable.
• Travel required (up to 30%).

Experience:

• Excellent understanding of QA, regulatory, nonclinical, clinical and biomarker functions to guide key assessment activities appropriate with the stage of development.
• Excellent technical knowledge, understanding and experience in applying regulatory requirements for conduct of nonclinical studies and bioanalytical method validation e.g. 21 CFR Part 58, OECD Principles of GLP, 21 CFR Part 11, GCLP and Bioanalytical Method Guidance.
• Experience with developing a biomarker internal and external audit program preferred.
• 12+ years of experience in bio-pharmaceutical development, with emphasis on nonclinical and bioanalytical method support.
• 6+ years of managerial experience overseeing GLP Quality.
• Experience performing audits of GLP testing, Central and biomarker labs and reviewing PK/TK, bioanalysis data.
• Experience in participating and hosting regulatory inspections.
• Experience working with CROs, vendors, and cross functional management.
• Demonstrated success leading and motivating cross-functional teams and managing direct reports.
• Ability to think critically, communicate effectively across broad spectrum of audience both internal and external, excellent written skills.
• Experience in outsourcing, vendor management, and interfacing with internal groups.

Education:

• Bachelors degree, Master’s degree (preferred).
• GLP QA certifications (preferred).

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