About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.
Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.
This is an exceptional opportunity for a seasoned eQMS professional to take a lead role as a system administrator for Aura’s new Zen eQMS. The successful candidate will have extensive experience in the oversight and system administration of eQMS’s. Experience in implementation support, UAT, training, document management, and as a user liaison is essential. This position will be expected to work in a highly collaborative, cross functional team environment, and be the “go-to” person for all things Zen.
Responsibilities include but are not limited to:
- System administration in Zen eQMS, Training and Quality Documentation
- Management of system security controls, access, and permissions
- Liaise with Zen users to resolve issues
- Proactively facilitate, and coordinate role-based curricula to support end-user trainings
- Monitor workflows and training records to ensure users complete tasks in a timely manner
- Perform archival duties as defined by 21 CFR Part 58, 210, 211, and other regulations
- In conjunction with the functional department management develop and deliver training and methods to demonstrate proficiency to individuals and groups, including new hire training, and annual GxP refresher training
- Liaise with authors of new and retired documentation to assure that impacted curricula are revised.
- Support activities including but are not limited to user assignment, workflow implementation, document management, and report creation.
- Serves as the technical expert for Zen QMS
- Manage/Support the implementation of electronic system processes as it relates to user requirements, UAT, implementation and training for document management and/or training
- Support ongoing activities related to changes/enhancements and upgrades on Zen eQMS
- Continuously support and develop GxP training courses and job roles to work with business areas to optimize training and support on time completion of training via curriculum management or as business needs arise. This also includes support of non-GXP Areas such as HR, Finance and Legal
- Provide training and maintain training documentation to support Zen QMS users and or training users on document management and/or training systems.
- Ensure employee onboarding and off-boarding activities are properly managed to ensure compliance.
- Compile and provide key performance indicators and metrics on a routine basis to Quality Management for distribution, as needed.
- Perform daily operational tasks within the ZEN eQMS to support user account modifications, data reporting, troubleshooting, and effectiveness checks.
- Assist end-users with system use, run reports for metrics
- Work with the provider to troubleshoot/remediate system issues
- Assist in validation of computer systems for use in a GXP environment
- Ensure correct templates and formatting are utilized for GXP controlled document types
- Participate in inspection readiness and inspection support activities, leading document retrieval actions
- Bachelor’s degree, preferably in a scientific or technical discipline
- Minimum of 4-5 years of experience in the pharmaceutical or related industry
- Experience with management and implementation of e-Quality Systems (ZenQMS, preferred)
- Must have GXP and Quality knowledge
- Experience with electronic document management and learning management systems is required
- Strong organizational skills, attention to detail, and knowledge/experience with electronic data management
- Ability to work independently
- Must possess excellent oral and written communication skills
- Demonstrated strategic and critical thinking skills.
Interested? Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.