Quality Systems Software Administrator
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We built Tempus to collect, structure, and organize data from disparate data silos into a comprehensive dataset to accelerate the pace of innovation and discovery in healthcare. For this role, we are looking for a candidate to join our Enterprise Systems team whose primary responsibility will be to plan, manage, and implement new quality systems and introduce improvements to existing systems.
- Serves as the primary point of contact for Quality management computer systems
- Partners with the Quality Organization to oversee implementation of and migration to a new eQMS
- Manages Systems Releases and Upgrades.
- Partners with Quality Assurance on execution of computer system user needs.
- Partners with vendor to support system release schedule.
- Supports and tracks UAT.
- Records information and details to define system SOPs.
- Qualifies system feature requests with internal business partners – with the ultimate goal of training teams to retain system workflows.
- Defines strategic prioritization and develops/ideates with solutions to make existing processes more efficient.
- Provides Technical Support.
- Oversees system troubleshooting.
- Manages User Access.
- Liaisons with Quality personnel to support inspection activities
- Manages and executes quality validation efforts to ensure company policies are compliant with 21 CFR Part 11, CAP, CLIA.
- Manages the generation, approval, and maintenance of validation documentation deliverables such as User Requirements Specifications (URS), Configuration Specification (CS), and Requirements Traceability Matrix (RTM), and standard operating procedures (SOPs) in accordance with ISO 13485, ISO 14971, cGMP, 21 CFR Part 11 and related regulatory requirements to ensure the system is maintained in a validated state.
- Manages the drafting, execution, and approval of qualification protocols and analyzes results to verify that acceptance criteria for validation protocols are met.
- Performs risk assessments on upgrades, changes, etc. to the eQMS system and analyzes the impact to the system, requirements, regulations, etc.
- 4-6 years of experience working with Quality with an understanding of audit protocols and technical eQMS administration
- Working knowledge or experience in a regulated environment specifically to 21 CFR 820, ISO 13485:2016 requirements, Iso 14971
- Regulatory (CAP/CLIA, FDA, ISO, etc) auditing familiarity
- Self-motivated with the ability to multitask and work effectively within a fast-paced environment
- Demonstrated ability to work independently and collaborate well across teams
- Proven verbal and written communication skills
- Familiarity with Compliance Quest, ETQ, Jama, or similar eQMS/Quality software preferred
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.