Senior Quality Assurance Specialist, Risk Management
Remote job description
Technical Operations & Process Sciences - Bothell, Washington
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!
The QA Risk Management Sr. Specialist is responsible for managing the day-to-day activities of the Quality Risk Management program. The position is responsible for training staff in the program; assisting staff with completion of day-to-day assignments / tasks; ensuring compliance with procedures; and implementing program improvements to align with current industry best practices. The position must be able to interact with staff at various management levels and make presentations to internal and external customers on specialized and highly technical aspects of the relevant programs.
- Manage the Quality Risk Management program, including:
- leading discussions with mid- to senior staff on status of key activities and risks within the program
- collaborating cross-functionally to plan and facilitate risk management activities across GMP functions, and ensuring the completion of mitigation actions
- assisting junior to mid-level staff with performing program assessments and activities
- developing new business processes
- developing and maintaining risk management tools for the assessment of sites (internal and external) and for the assessment of processes, programs, and systems
- developing and providing training for the processes and program
- processing complex records that may involve external parties
- developing new metrics, evaluating metrics, and reporting to department management.
- leading validation activities as a business process owner
- evaluating and managing software tools to support the business process
- Lead the successful completion of cross-functional projects
- Write/revise and collaborate on Quality directives, and approve standard operating procedures that impact multiple departments or programs based on industry best practices; ensure documents reflect current practices.
- Participate as an SME in audits and inspections, as needed.
- Represent Quality Systems on cross-functional teams or teams with external parties
- Lead continuous improvement activities that may involve a team
- Own and manage role-based training curriculums for business process
- Review staff training assignments
- Make independent decisions within the areas of expertise, with support from management on more complex issues
- Mentor and potentially supervise entry-level associates
- Other duties as assigned
- 10+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry.
- Working knowledge of current industry practices and standards.
- Advanced expertise with Office 365, especially Excel.
- Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.).
- Excellent written and oral communication skills.
- Demonstrated problem-solving skills and techniques commensurate with job level.
- Ability to manage routine and non-routine workload with little-to-no routine oversight.
- Bachelor's degree in relevant field; or Associate's degree +2 years of relevant experience in the biotech or pharmaceutical industry.
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.
Company name: IowaLifeScience
Remote job title: Senior Quality Assurance Specialist, Risk Management