Sr. Manager, Quality Assurance

## Sr. Manager, Quality Assurance Apply locations:
Chicago time type:
Full time posted on:
Posted Yesterday job requisition :
JR
** 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.

As the Director of Quality Assurance (QA), you will hold ultimate accountability for the management, strategic oversight, and scaling of Tempus’ clinical Quality Management System (QMS) and team. Operating at the intersection of cutting-edge AI and clinical compliance, you will ensure our global systems operate in accordance with ICH-GCP and applicable international regulations. This high-impact role uniquely oversees both our CRO business for pharmaceutical clients and Tempus’s own sponsored medical device clinical trials.
** Key Responsibilities & Core Ownership
** Champion Clinical Compliance:
Drive the strategic vision for the clinical QMS, ensuring robust compliance across all internal systems, pharmaceutical CRO clinical operations, and proprietary medical device sponsored studies.

Empower Cross-Functional Teams:
Act as the primary organizational mentor and subject matter expert on clinical validation architectures. You will partner closely with internal leaders to guide them through complex compliance ecosystems, fostering a culture of high-velocity education and alignment.

Design Team Architecture & Efficiencies:
Take an active, entrepreneurial role in shaping our QA organization. Collaborate with key stakeholders to brainstorm structural efficiencies, scale operations, and design how parallel quality roles can best collaborate for maximum impact.

Job Responsibilities:

* Collaborate with Executive Management to lead, implement, and continuously improve the clinical QMS, establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH.
* Oversee GCP framework for sponsored clinical trials to ensure required quality elements are strategically executed upon, risk-based, as appropriate.
* Oversee the clinical QA audit program, including development and maintenance of the internal, client, and vendor audit schedule.
* Oversee the clinical supplier/vendor quality qualification framework and approved vendor list.
* Manage and conduct qualification and ongoing audits of vendors and partners that have been contracted for clinical trial activities to assess adherence to applicable regulations.
* Conduct audits, including Internal, Investigator Site and Trial Master File.
* Host and support company regulatory GCP inspections.
* Oversee the clinical quality system document control process, including review and approval of controlled documents.
* Oversee the clinical CAPA and non-conformance programs.
* Provide Executive Management trends and metrics of the clinical QA program and CAPA status, at a minimum of annually.
* Support concurrent operational efforts by consulting on projects and representing QA in interactions with clients.
* Ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices.
* Assist with reports of suspected research misconduct investigation.
* Foster an environment that supports compliance and drives continuous improvement activities with emphasis on root cause analysis.
* Keeps current with GCP quality and regulatory surveillance, as well as trends, and shares information with applicable personnel.
* Ensures that clinical trial documentation is in compliance with applicable regulations and standards.
* Performs other duties as assigned
** Demonstration of Tempus Values:
*** Recognizes that the team is always stronger than the individual
* Seeks to inspire others by demonstrating consistently strong performance
* Treats people with respect regardless of role or point of view
* Listens well and seeks to understand before reacting
* Provides candid, helpful, and timely feedback to colleagues in line with GCP quality concepts and best practices
* Demonstrates curiosity about and contributes effectively to areas outside of their specialty
* Keeps the bigger picture in mind when making decisions
* Never stops learning
* Questions assumptions and…