Seagen

Senior Director, North Creek Site Quality Head

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:

As North Creek Site Quality Head, the Senior Director is responsible for establishing and maintaining the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. This position’s responsibilities include leading the site Quality organization (QA & QC) by providing leadership and guidance in quality decision making. The QC laboratories include both chemistry and microbiology teams. The Senior Director and Site Quality Head will lead the Quality Culture transformation at the site and drive operational effectiveness and compliance operations at the site. The Senior Director is also responsible for directing and providing leadership for the implementation of Seagen global standards and procedures to ensure quality decisions are made conforming to highest standards and in the successful operation of the Quality Organization.

The ideal candidate has a proven track record in leading mid-size Quality teams supporting biologic or monoclonal antibody production and sterile manufacturing of complex biotech products. Having a prior experience in operationalizing new facility from qualification to successful commercial manufacturing would be an advantage. The incumbent will be responsible for building and developing a high performing Quality team to ensure operations and quality systems at the site are operating in compliance with Seagen requirements and international GMP standards.

The Site Quality Head will be a member of the Site Leadership Team and a member of Seagen Extended Quality Leadership Team.

Responsibilities:

• Ensures that the Site Quality Management System is established, implemented, and resources are available to maintain its effectiveness in accordance with applicable global regulations.
• Directs the Quality Operations function to assure that all products manufactured meet customer, corporate, quality, and regulatory requirements and guidelines (ICH Q10)
• Directs the site Quality Control organization including analytical, microbial, environmental monitoring, and sample management groups
• Develop and lead an agile Quality organization at the site - hiring and developing top talents to create high performing teams and ensure succession planning through active training and development plans for all Quality staff at the site
• Lead the site Quality Culture transformation to ensure operational effectiveness and a right-first-time mindset across all operations at the site
• Drive continuous improvement activities at the site to ensure problems are proactively identified, prevented and issues resolved efficiently and sustainably
• Champion and foster a positive and quality compliance culture at the site in close collaboration with local stakeholders
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility and ensure timely remediation of issues identified
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the facility
• Ensures the facility, processes and systems are maintained in an audit and inspection ready state and ensure effective CAPAs are implemented to mitigate risks
• Lead and host compliance audits and regulatory inspections by competent regulatory authorities (e.g., FDA, EMEA, PMDA, MHRA, etc.)
• Establish and effectively manage the Site Quality annual operating budget within the assigned functional targets and objectives
• Ensure that Quality meets or improves on budget, cost, efficiency targets (KPIs) in line with TOPS business objectives

Qualifications:

• A minimum of 15+ years of experience in a life science, regulated industry (pharmaceutical or biotech)
• 10+ years of hands-on experience directing a quality function and overseeing GMP operations at a commercial manufacturing site
• Minimum of 10 years of people management and mentoring experience
• BS/MS degree or equivalent in scientific, quality-related field, biology, chemistry, or pharmaceutical studies, or an equivalent combination of education, training and experience
• Demonstrated leadership experience building and leading high performing Quality Assurance, Compliance, Quality Systems and Quality Control teams
• Expert knowledge and application experience in all aspects of Quality Management System in alignment with applicable global regulations (ICH Q10, 21CFR210&211, Eudralex Volume 4)
• Demonstrated leadership and partnership with manufacturing and operations to enable uninterrupted high quality and compliant product supply to patients
• Experience in site management of continuous improvement, operational excellence and six-sigma programs would be an asset
• Proven leadership in driving GMP compliance and implementing global regulations
• Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to influence executive leadership on complex technical and quality related topics with attention to detail and desire to achieve team and individual goals

Preferred Qualifications:

• Hands-on quality management experience with biologics, ADC production, and/or manufacturing products under aseptic conditions (EU Annex 1)
• Proven experience in leading Quality Culture transformation initiatives or organizational change management activities at a manufacturing site
• Demonstrated experience in successfully leading cross functional quality teams
• 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 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: 05/20/2022