The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The QA Senior Associate/Specialist position is responsible for managing vendor qualification and external compliance programs to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations.
- Maintain state of the art audit program
- Generate GMP audit and site visit schedules
- Facilitate planning, execution and follow up of vendor assessments
- Develop metrics and key performance indicators (KPIs)
- Perform audits
- Maintain approved vendor list
- Track audit commitments and ensure appropriate follow-up
- Establish auditor qualification program
- Maintain audit documentation in a compliant manner
- Establish and maintain Quality Agreements with external suppliers
- Manage Vendor Complaint Program
- Manage receipt, review and tracking of vendor Product Quality Reviews
- Regulatory Support
- Act as a liaison with external sites to fulfill requests to support regulatory filings, license renewals, etc.
- Develop a system for maintaining and tracking vendor GMP Certificates, manufacturing certificates; etc.
- Coordinate fulfillment of QP requests for external CMO documentation
- Inspectional support
- Ensure notification of vendor inspections are distributed internally and to partner as required
- Develop and maintain a system to track regulatory inspection histories for vendors
- Support regulatory inspections at CMOs. In conjunction with European office, act as a point of contact for CMOs when a vendor is inspected.
- Coordinate fulfillment of documentation and informational requests for vendor site inspections
- Knowledge of cGMP and applicable FDA regulations
- Bachelor's degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
- Very detail oriented team player with effective planning, organization, and execution skills
- Excellent communication skills with internal and external personnel essential
- Experience with electronic quality management systems is preferred
- Strong computer skills
- Ability to work effectively at a fast pace with cross functional departments
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Ability to anticipate and mitigate challenges
- Knowledge and hands-on experience in regulatory inspections, vendor audits, and vendor qualification is required
- Occasional travel up to 10-20% of time
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.