Manager, Quality Systems
Essential Duties & Responsibilities
- This position will report to the Vice President of Quality Assurance.
- The Manager, Quality Systems will be responsible for daily oversight of Eiger’s Quality Management System, including but not limited to the implementation and maintenance of Document Control (EDMS), Record Management, CMO & CRO Files and Audit Scheduling.
- This position is responsible for the management of Eiger’s GxP Training program.
- This function will support the implementation and maintenance of Eiger’s electronic Quality Management System (e-QMS), including but not limited to configuration and part 11 validation.
- The Manager, Quality Systems will be involved in the development and tracking of Quality Metrics and reporting of key performance indicators during annual Management Review.
- Additional duties include preparation and support for regulatory agency inspections and/or third party due diligence audits, CMC Documentation Review, and general QA project management support for CMC activities.
- Bachelor’s degree or a combination of equivalent education and work experience
- Professional with minimum 5 years experience in a Quality Assurance or Quality Systems role pharma, biotech or healthcare environment
- Hands-on experience managing electronic QA software systems
- Must have proficient software skills in Microsoft Word, Excel, Powerpoint and Outlook
- Strong interpersonal skills and the ability to work independently as well as part of an interdisciplinary team.
- Energetic, self-motivated, organized individual accustomed to working in a virtual company environment in a deadline-focused entrepreneurial setting
- Skilled in problem solving, root cause analysis, decision-making and corrective action
- Excellent written, verbal and presentation skills
About Eiger BioPharmaceuticals, Inc.
Eiger (Nasdaq:EIGR) is a publicly-traded, commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis.
Eiger is developing two complementary treatments for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approval. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). Outside the U.S., Eiger's established global Managed Access Program, expected to span greater than 40 countries, ensures all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.
For additional information about Eiger, please visit www.eigerbio.com.