Nicole Willsey
Quality Compliance Manager | GxP Documentation | Internal Auditor | R&D Quality | Clinical Project Management
- Role
- Quality Compliance Manager at Amgen
- Location
- Eugene, OR, US
- LinkedIn followers
- 500 followers
About Nicole Willsey
Strong background in the med device, pharmaceutical, clinical, and biotechnological industries. My expertise lies in developing procedures while effectively communicating complex technical concepts. I have successfully managed a wide range of global projects, overseeing all aspects from initiation to completion. As a certified Lead Auditor, I have a comprehensive understanding of FDA and ISO standards, a meticulous approach to quality assurance, and expertise in conducting thorough reviews and assessments to ensure adherence to GxP document management practices. My passion for all things STEM, combined with my diverse experience keeps has shaped me into a well-rounded professional. I am particularly interested in opportunities that allow me to showcase my natural abilities and apply my knowledge across various biomedical disciplines. Experience: Audit/FDA Inspection, Chemistry Manufacturing and Controls (CMC), clinical trials and clinical research, Compliance, FDA regs, ISO: 13485, 9001, preclinical study, project management, quality assurance and quality control, regulatory, clinical research, design and development, technical writing, medical writing, scientific writing, QMS, Doc Control, eTMF, Veeva Vault, TrackWise, Agile, documentation specialist.
Experience
Quality Compliance Manager
Jan 2026 — Present · Thousand Oaks, CA, US
Provide Quality Oversight and Expertise across R&D functions, supporting complex process improvement efforts and ensuring QMS principles, content controls, and tracking mechanisms are effectively applied.> Drive major process and documentation change initiatives, partnering with cross-functional leaders to implement end-to-end process documentation, remediate gaps, and address audit, inspection, and deviation findings.> Lead R&D controlled document strategy and governance, overseeing documentation lifecycle, periodic reviews, change control, and compliance with regulations and internal commitments.> Develop direct reports, teams, and tools that enable scalable documentation management, including workflows, communication strategies, and global process-change documentation frameworks.
Education
Oregon State University
Bachelor of Science - BS, Public Health- Health Promotion- Epidemiology
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