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Manager Work From Home Computer System Validation Csv Jobs in Illinois

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment * Strong ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment * Strong ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment * Strong ...

AO Globe Life

Entry Level Management-WFH

Galena, IL · On-site +1

$40K - $52K/yr

Imagine the freedom of working from home with a flexible schedule that empowers you to effortlessly ... management. 💪 Unionized Security: Benefit from the protections and perks of a unionized ...

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Manager Work From Home Computer System Validation Csv information

What is the difference between Manager Work From Home Computer System Validation Csv vs Computer System Validation Specialist?

AspectManager Work From Home Computer System Validation CsvComputer System Validation Specialist
CredentialsTypically requires a bachelor's degree in life sciences, IT, or related field; certifications like GxP, CSV certifications are commonRequires similar degrees and certifications, often focusing on CSV-specific credentials
Work EnvironmentRemote work, overseeing validation projects, managing teams, and ensuring compliancePrimarily on-site or hybrid, executing validation tasks and documentation
Industry UsageUsed in regulated industries like pharmaceuticals, biotech, and healthcareCommonly employed in similar regulated environments for validation activities

While both roles require similar credentials and industry knowledge, the Manager Work From Home Computer System Validation Csv focuses on overseeing validation projects remotely, managing teams, and ensuring compliance, whereas the Computer System Validation Specialist typically performs hands-on validation tasks on-site or in hybrid settings.

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Manager Work From Home Computer System Validation Csv jobs near you

Senior Quality Engineer

Tempus

Chicago, IL • On-site, Remote

Full-time

Re-posted 29 days ago

Job description

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.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters) or Aliso Viejo, California office.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). 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.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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.

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