Quality Assurance Manager
Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Seattle Genetics is seeking an energetic, passionate and experienced quality professional who will join the Quality Assurance team in the Quality Systems group.
As a QA Manager / Sr. Specialist, the position will be responsible for overseeing the GMP training program, managing the GMP training administrator, and interfacing with the other company training administrators (e.g. GCP/GLP, Commercial, etc.).
- Manage the GMP training program, including: developing enhancements to the training program; working with managers to assess and fill training gaps in their areas; reviewing and evaluating training metrics; leading continual improvement activities
- Perform training, as required
- Develop and manage a training certification program, and a train-the-trainer program
- Interface with training leads from other functional areas to ensure a cohesive and robust training program across the company
- Represent Quality Assurance on cross-functional teams participating in various operational programs as needed for continuous improvement activities
- Write/revise quality procedures or other department operating procedures
- Perform as Subject Matter Expert in audits and inspections, and provide support as needed
- Supervise and mentor associate level staff
- Bachelor's degree and 10+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
- Working knowledge of cGMP is required, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
- Understanding of adult learning principles
- Familiarity with electronic Learning Management Systems (LMS)
- Experience in developing training and training materials
- Able to integrate learning from industry conferences or guidance documents into company procedures
- Excellent written and oral communication skills required
- Familiarity with the ComplianceWire Learning Management System
- Strong computer skills and working knowledge of general MS Office applications
- Able to organize information in a consistent and readily retrievable manner
- Enthusiasm for the work and ability to proactively implement continual improvements desired
- Strong team player that can also work independently to achieve objectives
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.