Quality Assurance Project Manager at Tempus

| Chicago
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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 are looking for a Quality Assurance Project Manager who will lead standardization and implementation of global process improvements that drive product and process quality and compliance across the organization. This role will collaborate with multiple sites and cross-functional stakeholders.
This position will report to the Vice President, Quality Assurance. 

Responsibilities

  • Leads complex projects related to QMS (Quality Management System) and QA activities, including process improvements and operational projects to improve process and product quality.
  • Monitors project scope, timeline, and resources to assure project completion on schedule and as per expectations.
  • Familiarity with regulatory requirements and best practices in QMS and regulatory compliance.
  • Lead small, medium, and large cross-functional and multi-site initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
  • Develop high level reporting strategy and metrics to be reported to enable executive management to take action to improve process and product quality.
  • Work with a cross-functional team to implement metric reporting.
  • Assisting QA leadership with communication of project status and needs to executive management team members.
  • Develop and deliver training content for QMS processes and regulatory compliance.
  • Other QMS and QA related duties as assigned. 

Required Qualifications

  • Bachelor's degree or equivalent in Biology, Chemistry, or related field.
  • 8+ years' experience in a medical device, IVD or pharmaceutical industry, or equivalent combination of education and experience.
  • Advanced knowledge of and application of best practices in Quality Systems, Quality Engineering, Quality Assurance, Quality Management, and quality metrics/statistics reporting required.
  • Proven ability to collaborate and influence with or without authority, facilitate groups with diverse perspectives and align teams.
  • Demonstrated and impactful project management and leadership skills (PMP preferred), including the ability to lead multi-site, cross-functional teams, and resolve quality-related issues in a timely and effective manner.
  • Multitasks, prioritizes and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Solid communication and interpersonal skills, with ability to effectively communicate at multiple levels in the organization.
  • Knowledge of FDA Quality System Regulation (QSR), GMP, ISO 13485:2016, ISO 14971, MDSAP and EU-IVDR is a plus.
  • eQMS experience is a plus.
  • Previous experience with external/regulatory agency audits/inspections.
  • Ability to travel as required.


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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • GolangLanguages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • SqlLanguages
    • GCPLanguages
    • ReactLibraries
    • ReduxLibraries
    • Node.jsFrameworks
    • SparkFrameworks
    • TensorFlowFrameworks
    • Microsoft SQL ServerDatabases
    • MySQLDatabases
    • PostgreSQLDatabases
    • SQLiteDatabases
    • tableuAnalytics
    • JIRAManagement
    • SalesforceCRM

Location

600 WEST CHICAGO AVENUE, Chicago, IL 60654

An Insider's view of Tempus

What makes someone successful on your team?

We value creativity in ideation, autonomy in execution, and a healthy tendency to always question the status quo.

Ash

Lead Data Scientist

What are Tempus Perks + Benefits

Tempus Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Mental Health Support Platform
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Pair programming
Open office floor plan
Diversity
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Onsite Gym
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Stocked Kitchen
Some Meals Provided
Happy Hours
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Diversity Program
Lunch and learns
Promote from within
Time allotted for learning
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