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Executive Director Global Head of Quality Control

Employer
NewYorkLifeScience.com
Location
Bothell, WA
Closing date
Dec 10, 2021

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Executive Director, Global Head of Quality Control
Technical Operations & Process Sciences - Bothell, Washington

Description

Summary

The Executive Director of QC is responsible for the successful development and execution of an integrated Quality Control Strategy across Seagen GMP laboratories. The position is responsible for the oversight of all QC activities across our internal manufacturing sites (DS, DP and Packaging) and our extensive network of Contract Manufacturing Operations (CMO) where our commercial and clinical products are manufactured and tested. The incumbent will manage and develop the QC staff for growth, focusing on scaling up the organization, driving performance, and developing technical and leadership capabilities in support to a robust succession planning. The position requires a broad knowledge of quality as well as proficiency with the analytical and bioanalytical methods used in control systems for in-process testing, release and stability monitoring of biological products and small molecules. Proficiency with cGMPs and multi-national regulations is required. Success is achieved through effective collaboration with internal and external partners in regulatory, analytical sciences, process development and technical operations to develop and execute the overall CMC strategies. Additionally, this position is responsible to author and review relevant CMC sections and contribute to HA communications, briefing documents for scientific advisory meetings as well as responses to health authority information requests. The Executive Director QC is a permanent member of the Seagen Quality Leadership.
  • Responsible for leadership of all QC activities across Seagen manufacturing sites and CMO networks
  • Provide strategic and tactical leadership to the QC organization ensuring the execution of QC responsibilities within the Seagen Quality Systems
  • Implement and manage a GMP compliant laboratory control program -across sites and central operations- in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods transfer and validation, and stability
  • Ensure harmonized practices across the Seagen network of laboratories (internal sites, CMOs and central laboratories)
  • Ensure the testing of products is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs, and local Health and Safety requirements
  • Ensure data integrity compliance with all current regulatory requirements applicable across all systems and operations in QC laboratories
  • Recruit, retain and develop QC talent responsible for the management of QC operations and staff to ensure all laboratory activities are conducted in compliance with GMP and Seagen standards
  • Develop performance goals and objectives for the QC team, and drive/monitor performance against objectives
  • Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve
  • Drive compliance throughout the function and represent QC during regulatory inspections
  • Write and/or review and approve assigned CMC sections for new and amended IND/IMPDs and license applications (MAA/BLA/NDA)
  • Develop and maintain a strong and effective relationships with internal stakeholders and partners
  • Lead team and provide oversight for in the management of laboratory and site investigations and reports in response to OOS, invalid assays, and/or negative trends
  • Assure quality risk assessments against regulatory compliance requirements is conducted across all QC laboratories and risks identified appropriately and proactively mitigated
  • Ensure that QC meets or improves on budget, cost, and efficiency targets (KPIs) in line with TOPS business objectives

Required Qualifications:
  • The ideal candidate for this position will have demonstrated in-depth experience of establishing and managing QC functions associated with the GMP production and testing of biologic products and small molecules in both clinical and commercial settings.
  • Educational background includes a degree in life science (Post-graduate degree in a related field is a plus) in chemistry, biology, biochemistry or any related technical discipline.
  • Minimum of 18 years' experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
  • Minimum of 10 years' experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation.
  • Minimum of 8 years in direct supervision of laboratory staff or project management. Experience in conducting analytical investigations on small molecule and large molecule.

Preferred Qualifications:
  • Hands-on QC testing experience with biologics (including ADC), aseptic products (both liquid and lyophilized forms) and small molecules
  • Demonstrated experience in successfully leading cross functional QC teams in a matrix environment to deliver your QC strategic vision
  • Strong project management skills and experience managing multiple projects at the same time is essential
  • Demonstrated excellence in written and verbal communication
  • Demonstrated ability to work cross-functionally and develop strong business partner relationships in a matrix-environment across organizations
  • Ability to manage and lead in a fast pace and high change environment
  • Fluent in written and spoken English

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.

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.

NewYorkLifeScience.com, owned and published by Info.Resource, Inc. , is a resource
for the life science industry in the state of New York.

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