Senior Manager, Quality Assurance Systems Monitoring (Remote US)
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!
A Quality Assurance Sr. Manager (Systems Monitoring) in Quality Systems is responsible for managing the strategy and direction of multiple quality programs or processes, such as risk management, data integrity, and management review, etc. The position is responsible for training staff in their programs; 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.
People management responsibility is expected for junior to mid-level staff.
Requirements or Responsibilities:
- Set strategy for multiple quality processes or programs based on guidance from senior leadership, including:
- leading discussions with senior staff and leadership teams on status of key activities and risks within the program
- developing new business processes that have cross-organizational impact or external impact
- interpreting complex metrics and evaluating trends, and reporting to cross-functional management
- leading validation activities as a business process owner
- Systems Monitoring specific responsibilities include:
- Risk Management: setting strategy for maintenance and evolution of the program; collaborating cross-functionally to facilitate risk management activities within all GMP areas; ensuring communication of risk management status updates to senior leadership; and overseeing activities such as risk management team meetings, and creation and maintenance of quality risk management tools and methodologies for use across the organization
- Management Review: setting strategy for maintenance and evolution of the program; ensuring preparation and communication of Seagen management review at Site, Affiliate, Corporate and Executive level; reporting on the effectiveness of the QMS and any need for improvement identified through the management review of all levels; and oversight of mitigation actions and deliverables from management reviews
- Data Integrity: setting strategy for maintenance and evolution of the program; ensuring data integrity practices and procedures meet industry standard; overseeing the development and execution of company data integrity policies; ensuring communication of risk management status updates to senior leadership; and collaborate cross-functionally to ensure data integrity evaluations are embedded in applicable GMP processes
- Lead the successful completion of cross-functional projects or sponsor projects within the department
- 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 leadership teams
- Manage a portfolio or suite of interrelated continuous improvement projects
- Review staff training assignments
- Determine how to execute on projects and goals set by senior leaders
- Lead the hiring, mentoring, and developing of staff
- Participate in development of strategy and goals for staff
- Other duties as assigned
- 14+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
- 2+ years of people management experience
- Working knowledge of current industry practices and standards, especially with ICH Q9 (quality risk management), PIC/S data integrity standards, and ICH Q10 management review
- Advanced expertise with Office 365
- 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 of direct reports
- 5+ years of people management experience
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.