Senior QA Lead: Client-Facing & Regulatory Quality

Tempus; Chicago (IL); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Incentive compensation

Restricted stock units (RSUs)

Medical benefits

Job summary

Tempus is seeking a Quality Assurance Specialist to join our team in Chicago. You will serve as a QA partner for client-specific projects, coordinating quality activities, timelines, risks, and follow-up actions, while collaborating with cross-functional teams to integrate quality requirements into plans.

Ideal candidates have 1–3+ years in QA/QMS within FDA-regulated settings, strong communication skills, and the ability to manage multiple priorities with minimal supervision.

Qualifications

• Experience coordinating quality activities across multiple workstreams.
• Ability to communicate quality requirements clearly to clients and internal teams.
• Familiarity with quality management systems and regulatory standards.

Responsibilities

• Serve as a QA partner for assigned client-specific projects, coordinating quality activities, deliverables, timelines, risks, and follow-up actions.
• Collaborate with project, product development, operations, regulatory, and other cross-functional teams to integrate quality requirements into project plans and execution.
• Act as a professional, responsive point of contact for clients and external partners on assigned quality matters.
• Support client onboarding, pre-qualification, and project-specific quality questionnaires; collect, review, and coordinate supporting documentation.
• Communicate project status, quality risks, decisions, and action items clearly to internal stakeholders and external client teams.
• Contribute to project planning and governance, including tracking milestones, dependencies, deliverables, and quality-system commitments.
• Manage and track NCRs, CAPAs, deviations, and related investigations, effectiveness checks, and follow-up activities associated with client projects.
• Maintain awareness of applicable regulations and standards and communicate relevant changes or requirements to project stakeholders and management.
• Comply with documented Quality Management System (QMS) procedures and complete assigned training on time.
• Participate in internal, external, client, and regulatory audits as a project quality representative; support response development and closure of project-related observations.
• Perform other duties and projects as assigned, with flexibility to support additional quality system areas.
• Review QMS documentation against applicable regulations for international compliance.
• Remain up to date with applicable regulations to communicate changing requirements to Management.
• Help identify opportunities for process improvement related compliance and inspection readiness.
• Collaborate with cross-functional teams to collect documentation and support compliance activities.
• Perform other duties and projects as assigned and ability to be flexible in supporting various quality system areas.

Skills

Project management

Client-facing & audit-facing

Communication skills

Detail-oriented

Self-motivated & adaptable

Job description

Tempus is seeking a Quality Assurance Specialist to join our team in Chicago. You will serve as a QA partner for client-specific projects, coordinating quality activities, timelines, risks, and follow-up actions, while collaborating with cross-functional teams to integrate quality requirements into plans.

Ideal candidates have 1–3+ years in QA/QMS within FDA-regulated settings, strong communication skills, and the ability to manage multiple priorities with minimal supervision.