Seagen
Quality Program Specialist (Risk Management)
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!
Summary:
A Specialist in Quality Programs is responsible for managing the day-to-day activities of a quality program or process, such as change management, data integrity, deviations, etc. The position is responsible for training staff in their 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 mentor junior staff.
Principal Responsibilities:
- Manage the Risk Management program, including:
- assisting junior to mid-level staff with performing risk management assessments and activities
- developing new procedures and business processes as part of a team
- developing and providing training for the process or 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
- Guide the successful completion of department projects and may function in a project leadership role
- Write/revise, review, collaborate on, and approve program or department standard operating procedures; and ensure documents reflect current practices
- Participate as an SME in audits and inspections under the direction of management, as needed
- Represent Quality Systems on cross-functional teams or teams with external parties
- Lead continuous improvement activities that may involve a team
- Make independent decisions within the defined procedures and practices of the quality program they lead, with oversight from management on more complex issues
- Mentor entry-level associates
- Other duties as assigned
- Stay informed about industry trends and review new regulatory guidance
Required Qualifications:
- 8+ years in regulated industry, preferably in the biopharmaceutical or the pharmaceutical industry
- Working knowledge of cGMP, including ability to understand and apply ICH guidance regulatory guidance, and pharmaceutical organization guidance
- 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 minimal 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.
The hiring pay range for this position is $98,000 to $127,000 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 02/10/2023
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