Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
Based in our Foster City office, the QA Manager / Sr. Manager supports Mirum’s GxP document management and training programs. The candidate will manage, and process paper based and electronic GxP documents through a validated electronic document management system (EDMS). In addition, the individual will also support the in-house training program for GxP activities.
- Process GxP controlled documents in the EDMS, working closely with functional areas to route new documents and revise or retire existing documents through the review and approval process.
- Organize and process paper documents into the EDMS and for off-site storage and retrieval.
- Coordinate off-site scanning and storage services and maintain associated document lists.
- Support the electronic Learning Management System (LMS) and in-house training program.
- Support training development activities including the development of training courses/exams and training qualification.
- Work closely with functional area heads and staff to maintain inspection ready GxP training records.
- Provide assistance and training on EDMS and LMS access and use, as needed.
- Develop and revise documents associated with GxP Document Management and Training, as needed.
- Work with IT to maintain EDMS and LMS validation status through IT change control.
- Maintain the Quality page on the company intranet.
- 4-year degree or comparable experience in the industry.
- Quality professional with hands-on experience maintaining document control or training processes in pharmaceutical or medical device industries.
- Experience with EDMS and LMS systems is a plus.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Excellent computer skills with working knowledge of MS Office such as Word and Excel, Visio, and Adobe Acrobat professional.
- Good knowledge of FDA regulatory requirements related to cGMP document management.
- Excellent written and verbal communication skills.
- Strong interpersonal skills.
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
- Ability to effectively participate on multi-disciplinary teams.
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
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