Senior Quality Specialist, GCP Quality Assurance (QA)

| San Francisco, CA, USA | Remote | Hybrid
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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.Summary:

The Senior Quality Specialist is responsible for assisting in the coordination and implementation of Good Clinical Practice (GCP) related quality assurance activities. These responsibilities include supporting the execution and maintenance of the audit program focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and Tempus Compass policies and procedures.  The Senior Quality Specialist manages the tracking of audit findings, Corrective and Preventive Actions (CAPAs) and Non-conformances and assists with sponsor audits, as needed.  The Senior Quality Specialist works with the QA Management and Department Heads to manage, assign and track training via the Learning Management System (LMS).  

Job Responsibilities:

  • Collaborate with QA Management to implement the quality management system (QMS).
  • Coordinate and manage Tempus Compass policies, procedures and associated controlled documents throughout the development, review, revision and archiving process. 
  • Ensure processes and procedures are updated to reflect regulatory trends, technological changes and best practices.
  • Track and perform follow up activities for audit findings, CAPAs and Non-conformances.
  • Compile trend analyses of GCP quality system metrics such as audit findings, CAPAs and Non-conformances. and report to QA Management. 
  • Assist in the preparation and conduct of internal and external audits as needed and ensure compliance with associated processes.
  • Support concurrent clinical efforts by consulting on projects and representing QA in interactions with internal and external customers.
  • Interface with clients, internal and external stakeholders, and vendors, as needed.
  • Support company regulatory GCP inspections, as needed.
  • Manage, assign and track corporate, regulatory, controlled document and project-specific training via the LMS. 
  • Maintain the master training matrix and updated upon release of new, revised or retired controlled documents. 
  • Work closely with management to evaluate and identify trends and training needs.
  • Report metrics for corporate, regulatory, controlled document and project-specific training compliance trends to QA Management, Department Heads and Project Managers.
  • Support external controlled requests from sponsors or third party vendors.
  • Work effectively with cross-functional teams to address and resolve quality issues.
  • Performs other duties as assigned.

Demonstration of Tempus Compass Values:

Consistently strives to demonstrate the following Tempus Compass 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. 
  • 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 offers suggestions for improvement. 
  • Focuses on results rather than process and seeks to minimize complexity when process is required.
  • Identifies and addresses root causes, not symptoms. 
  • Demonstrates poise in stressful situations. 
  • Strives to always do the right thing.
  • Questions actions that are incongruent with Tempus Compass values.  

Minimum Qualifications:

  • Bachelor’s degree required.
  • 5+ years of working and managing controlled documents and training in a regulated environment.
  • Experience working with quality system elements (e.g., document management, training and compliance, CAPA and non-conformance management, performing root cause analysis (RCA), and quality systems management).
  • Knowledge of ICH-GCP guidelines, and other applicable regulatory guidelines
  • Detail oriented with excellent communication and interpersonal skills, as well as the ability to interact at multiple levels of the organization, manage multiple priorities, and deliver high quality results.
  • Highly motivated individual with excellent problem-solving skills and the ability to make difficult decisions and provide sound Quality/Compliance direction to personnel as applicable.
  • Strong background in delivering quality results through effective planning and time management.
  • Ability to perform multiple tasks and manage changing priorities.
  • Proficient in Microsoft Office Suite (MS Word, Excel and PowerPoint).

Preferred Qualifications:

  • 8+ years of supporting QMS in a CRO or Pharma.

#LI-Remote

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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Location

Our Redwood City office is located in a waterfront neighborhood at the heart of Silicon Valley, providing convenient access to tech hubs and boasting a thriving business scene. With excellent transport options and a range of dining choices, it's a dynamic hub for professionals and tech enthusiasts.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

How does the company support your career growth?

I am always looking for the next opportunity to grow my career, and Tempus has a wealth of opportunities in many departments. Through emerging leaders programs and ongoing conversations with my managers, Tempus has always been supportive in guiding me to find work that is fun, interesting, and maximizes my potential.

Aaron

Senior Operations Manager

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
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
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance + Wellness
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave
Generous parental leave
Family medical leave
Vacation + Time Off
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Professional Development
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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