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.

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.

The Senior Manager, Quality Assurance plays an integral role in overseeing the quality activities across all Tempus labs and providing support and guidance for the strategic vision of the department. Areas of responsibilities include overseeing the audit and compliance program, as well as related nonconformances (NC) and corrective and preventive actions (CAPA); and Document Control, in accordance with FDA QSR (Quality System Regulation), ISO 13485, CAP/CLIA/NYS requirements and other applicable global regulations. This individual also supports the Quality Management System (QMS) activities that comply with CLIA/CAP/NYS requirements for the clinical laboratories.

Responsibilities include the following. Other duties may be assigned.

• Audits & Inspections: Lead and support internal, second-party client, and third-party regulatory inspections/audits, formal communications, registrations, and reporting to FDA, EU notified body (NB), CAP, CLIA, and NYS. Ensuring inspection readiness, preparing and training subject matter experts, creating and utilizing audit tools for efficiency and effectiveness.

• Audit Findings and Resolution: Ensure the audit finding framework aligns with the issue management process and that audit findings are managed accordingly (via NC and/or CAPA) in accordance with FDA 21 CFR 820, ISO 13485, CAP/CLIA/NYS. Drive continuous improvement to maintain a sustainable, streamlined framework that enables simplification and standardization. Act as a change leader, responsible for execution of major readiness and compliance initiatives.

• Continuous Improvement: Oversee audit module build out in eQMS to bring automation and efficiency to the overall audit/inspection process. Drive opportunities for improvement and address potential gaps/preventive actions. Support and improve compliance status of various QMS activities. Lead eQMS implementation across multiple QMS activities.

• Cross-Functional & Fit-for-Purpose QMS: Partner cross-functionally to develop and implement policies and procedures for a fit-for-purpose QMS, balancing the needs of various product types while standardizing and aligning systems across quality areas.

• Team Management & Development: Direct and develop reporting staff in their day-to-day QMS activities. Supervise and provide performance feedback to direct reports, ensuring professional development and high-quality work output.

• Quality Metrics & Reporting: Provide input on quality assurance metrics on audit and inspections, as well as for other related assigned QMS duties.

• Strategic Execution & Efficiency: Strategize on building efficiencies within areas of responsibility to achieve departmental goals, align with the strategic vision, and execute process improvements. Lead and/or support other duties as assigned.

• This is an on-site hybrid position (3 days/week).

Required Education & Experience:

• Bachelor’s Degree in Engineering or Science field or with 8+ years of relevant working experience in a clinical laboratory/medical device/Diagnostic company, with a minimum of 5 years working on QA activities such as audits, complaints, NC, CAPA, Document Control.

• Working knowledge of CAP/CLIA/NYS regulations and requirements to support relevant QMS activities.

• Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD/IVDR, and other applicable quality and regulatory standards).

• QA experience with Class 2 or 3 medical device development and/or in a molecular testing laboratory (LDTs) is preferable.

• Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills.

• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.

• Ability to manage multiple tasks with limited supervision.

• Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.

• Strong project management expertise and ability to focus on execution of strategic decisions while balancing conflicting priorities.

• Travel may be required up to 5-10% of the time.

Chi: $100,000 - $160,000

The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

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.