Seagen

Associate Director Quality Partnership Management (Remote US)

Technical Operations & Process Sciences - Bothell, Washington

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

Associate Director of Global Quality Partnership is responsible for executing and supporting the coordination of all Global Quality related activities as needed across Seagen to support key strategic business partners and alliances, Seagen affiliate sites, and corporate business units.

The Associate Directory Global Quality Partnerships supports the development, implementation, integration, and execution of quality processes in accordance with Seagen Quality Management Systems including early-stage due diligence activities, integration of new assets into Seagen, and routine management of business partners and alliances.

Responsibilities:

• Act as the single point of contact for Quality with all Seagen Corporate functions and accountable for all activities related to the Due Diligence, Integration, and day to day management of strategic partnerships and alliances.
• Lead the due diligence activities for Quality through the evaluation of new targeted assets, coordination of Quality Subject Matter Experts to conduct a comprehensive evaluation of the asset and coordinate due diligence audits with the compliance organization.
• Lead strategic Quality negotiations with high impact partnerships and alliances including negotiation of Quality Agreements, providing input to term sheets, and ensuring appropriate Quality Requirements are defined in the Master Supply/Distribution Agreements.
• Develop quality assessment process and tools ensuring risks are identified and mitigation plans are in alignment with business functions.
• Collaborate on the development of integration strategies for assigned projects and lead the implementation of Quality processes to manage integration of new assets into Seagen Global Quality.
• Ensure key integration activities and timelines are clearly defined and agreed upon across all impacted Global Quality functions to ensure all appropriate compliance elements are met.
• Liaise with peers and team members across the Quality organization ensuring the development or revision of Quality Management Systems are aligned with partnership and alliance needs and expectations.
• Manage day to day interactions with partners and alliances ensuring timely resolution of Quality related activities or issues.
• Coordinate the management of post marking quality issues such as complaints and deviations identified in partner territories.
• Act as the single point of contact for partner related quality topics and liaise with functional groups within Global Quality.
• Support and coordinate regulatory requests from partners to facilitate successful registrations or updates to existing submissions in their territories.
• Coordinate and facilitate partner Quality representative visits and audits. Coordinate specific activities or requests related to audits of Seagen business operations by partners or alliances.
• Participate in regulatory inspections at Seagen in relation to the product supplied through partnerships and alliances.
• Build and maintain strong partnerships with internal manufacturing network, supply chain operations, and relevant contract manufacturing sites to ensure alignment with the key strategic priorities from partners and alliances.

Qualifications:

• 14 + years of demonstrated broad experience of the Quality functions in a GMP environment combined with hands on experience with the production of biologic products and small molecules in both clinical and commercial settings.
• 5 years’ experience managing strategic partnerships or commercial alliances for Quality in a commercial or clinical setting.
• Educational background including a degree in life sciences such as chemistry, biology, biochemistry, or any related technical discipline.
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Demonstrated excellence in written and verbal communication skills.
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships.

Preferred Qualifications:

• Broad Quality Management experience with biologics (including ADC), aseptic products (both liquid and lyophilized forms) and small molecules.
• Demonstrated experience successfully working in cross functional teams in a matrix environment.
• Ability to manage and lead multiple projects and programs at the same time in a fast pace and high change environment.

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.

Seagen 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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/22/2022