Seagen

QA Manager Warehousing & Distribution

Technical Operations & Process Sciences - Bothell, United States

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!

Position Summary:

The QA Warehousing & Distribution Manager, Americas supports quality oversight of business partners (e.g., Distributors, Logistic providers, or exclusive wholesalers), for the assigned territory “Americas- (United States and Latin America)” and will closely collaborate with cross-functional internal and external partners at various management levels. The position is responsible for compliance regarding all internal policies / procedures and local regulations in the field of Quality Assurance as relevant to the territory. The position will provide Quality support for commercial product launches and new market and/or product registrations in the territory. Ongoing responsibilities for oversight of distribution partners will include performance monitoring, Quality Agreement maintenance and revisions, deviation & change management, and Quality review and approval of business documentation. The role will also support ongoing development of the Warehousing & Distribution global team through process and procedure development and/or improvement and ownership of associated projects.

Principal Responsibilities:

• Development, Implementation, and maintenance of local or regional Quality Management System as required
• Serve as a liaison for the region with all parts of the Seagen Quality organization, including executive leaders
• Support external inspections and audits in the region - closely collaborate with the relevant functions for preparation and during execution of the inspection including coordination of follow-up actions and CAPA plans Responsible for maintaining and following Quality Agreements with distribution providers/partners in the territory
• Support new & routine qualifications of distribution business partners
• Understand and support needs and priorities in partner markets, specifically for new product launches and market registrations. Work with leaders in other relevant functions to ensure full understanding and alignment across Seagen standards and procedures
• Provide Quality support for potential falsified or counterfeit medicines, recalls or any requests from Regulatory Authorities within the territory
• Coordinate/Support the handling of Pharmaceutical Complaints (PC), temperature excursions, and any deviations from distribution business partners
• Management of Change Controls and deviations relevant to commercial distribution and distribution business partners, including support for markets outside of the Americas territory
• Tracking of any non-compliance with respect to local requirements and regulations
• Ownership of global distribution quality key performance indicators, including data gathering, ongoing monitoring, trending, and reporting
• Escalation of unsatisfactory performance trends, and cross-functional collaboration for initiation of remedial action
• Continuous analysis of current processes against regulations, standards, and industry best practices to identify & take ownership of improvement opportunities
• Ongoing responsibility for quality processes and systems including training, document management, and Veeva applications
• May act as the Designated Representative for state board licensing

Required Qualifications:

• At least 10+ years of Quality Assurance experience in global pharmaceutical or biologics company
• Bachelor’s degree or an associate’s degree with 2+ years in relevant field (in addition to
• 10+ years of relevant experience)
• Experience with Distribution and/or Logistics Quality management
• Proficient knowledge of current GMP and GDP regulations
• Familiar with LatAm GDP requirements and standards (e.g., Brazil, Argentina, or Mexico)
• Recall and/or market action experience
• Collaboration with leadership at external partners, preferably global partners
• Excellent communication (oral and written) and presentation skills
• Project management skills, process-oriented
• Audit experience is an asset
• Expert knowledge of quality management systems
• Experience leading projects that require cross-functional cooperation
• Highly organized and able to make decisions with business impact Communication of priorities, progress, and delays/issues to leadership
• Intermediate proficiency in Spanish language (oral and written)
• 3 years of full-time employment history with a pharmacy, manufacturer or wholesaler in a capacity related to distribution and record keeping for prescription drugs

Preferred Qualifications:

• Fluent in Spanish language (oral and written)
• Extensive knowledge and experience with 3rd party distribution in Latin America
• Certified Quality Auditor
• Experience with Regulatory Operations
• Master’s level education in a science related field

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.

The hiring pay range for this position is $121,000 to $156,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/22/2023