Anissa Irwin
Sr. Director, Quality Systems
- Role
- Sr Director, Quality Systems at Immunome, Inc.
- Location
- Portland, OR, US
- LinkedIn followers
- 500 followers
About Anissa Irwin
Highly motivated and results driven Quality/Compliance/Technical Regulatory leader with extensive experience and a proven track record of delivering value and innovation in world-class manufacturing organizations. I am an engaged and agile servant leader with excellent problem-solving, collaboration, and communication skills including successful interactions with health authorities worldwide. Expert in Quality Systems development and management, Supplier Quality, preparations for Regulatory Filings and Inspections and development and delivery of compliance based training programs. Demonstrated success in building and leading high performing technical teams and developing/coaching individuals in reaching their full potential.Additional skills:• Vendor Quality Management• GxP Compliance and strong knowledge of domestic and major Global Health Authority Regulations.• Development and implementation of robust and efficient Global Quality Systems including but not limited to Technical Change Control, Controlled Document Mgmt, DMS, CAPA, Product Complaints, Site Compliance, Inspection Readiness, QSMR.• Project Management• Pragmatic and process focused problem solver who stays calm under pressure.
Experience
Sr Director, Quality Systems
May 2025 — Present · Bothell, WA, US
Education
University of California, Santa Cruz
Bachelor of Arts (BA)
1987 — 1991
University of La Verne
MBA, Executive Management and Healthcare
1995 — 1999
Skills
- Cross-Functional Team Leadership
- Change Control
- Quality System
- 21 Cfr Part 11
- Capa
- Gxp
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Corrective and Preventive Action (Capa)
- Biopharmaceuticals
- Quality Assurance
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