Seagen
Senior Manager, GCP/GLP Global Audit Strategy
Development - 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!
Position Summary:
This role will support the overall management of the GCP/GLP Quality Assurance audits in support of the Seagen Research & Development Quality Management System (R&D QMS). The role will participate in building, promoting, and continually improving the GCP/GLP compliance program which utilizes a risk-based methodology. The individual is responsible for demonstrating project management skills and leadership abilities to effectively influence and mentor a team of auditors.
Principal Responsibilities:
- Manage the end-to-end processes related to the planning, conduct and reporting of GCP/GLP audits
- Mentor and coach auditors on tactics and techniques across audit types
- Train and manage contract auditors
- Collaborate within RDQ on investigator site, vendor, and internal audit strategies
- Lead and/or collaborate with colleagues to develop audit plans for assigned projects and manage audit plan execution, reporting and follow-up
- Report serious compliance issues to senior management
- Work closely with the RDQ eSystems Compliance group to support electronic systems related activities (e.g., audit planning, ensuring that electronic systems are validated, issue management)
- Manage/Lead and/or perform international GCP/GLP routine and complex audits including but not limited to investigator sites, internal processes, and vendors
- Provide trending analysis to ensure proper process control of GCP/GLP activities
- Assist in regulatory agency inspections
- Evaluate, write, and/or review operating procedures, guidance documents, and training material
- Perform other activities in support of an integrated cross-functional quality management system (QMS)
Required Qualifications:
- Demonstrates proficiency (teaches others, makes improvements) of key areas of responsibility, which is typically associated with a Bachelor’s degree, and 5 or more years in GCP, GLP, and/or GVP Auditing
- 7 or more years of relevant experience in pharmaceutical industry
- Must have significant working knowledge of international GCP and/or GLP audit and compliance
- Proficient in Microsoft Office suite
- Ability to travel up to 30%
- Proficient in the following knowledge areas:
- GCP
- Clinical Development Process and Operations
- Auditing Techniques and Methods
- Regulatory Authority Inspection Processes
- Audit Plan and Compliance Program Design
- Proficient in the following competencies:
- Team Leadership
- Time Management
- Interpersonal Skills
- Analytical Skills
- Decision Making
- Problem Identification and Resolution
- Demonstrated ability in:
- Developing and delivering multi-mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences
- Gaining the confidence and trust of others through honesty, integrity, and authenticity
- Making good and timely decisions that keep the organization moving forward
- Operating effectively, even when things are not certain, or the way forward is not clear
- Planning and prioritizing work to meet commitments aligned with organizational goals
- Building partnerships and working collaboratively with others to meet shared objectives
- Seeing ahead to future possibilities and translating them into breakthrough strategies
- Creating a climate where people are motivated to do their best to help the organization achieve its objectives
Preferred Qualifications:
- Experience with audit management/CAPA management programs
- International auditing experience
- Auditor or Audit Program Management Qualification/Certification
- Oncology therapeutic area QA experience
- Ability to identify process improvement opportunities
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 $138,000 to $178,000 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: 08/25/2023
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