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Director, Software Quality

Employer
Freenome
Location
South San Francisco, CA
Start date
Nov 19, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

 

About Freenome 

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.  To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

 

Freenome’s Director, Software Quality will be involved in the implementation, support and continuous improvement of software quality management system (QMS) and software development life cycle (SDLC) framework, in accordance with FDA's Quality System Regulation (QSR), ISO 13485 and other applicable regulatory requirements, as well as best practices in the software industry.  This position will report to the Senior Director of Quality, and will be responsible for providing leadership, vision, and direction for premarket and postmarket software validation and other software activities for the software and AI/ML components of Freenome’s products, and other software supporting these products.

Your contribution:

  • Lead development of quality management systems necessary for compliant software development, validation and verification, especially with respect to AI/ML, including processes for product maintenance and change control management.
  • Lead and execute company strategies for all software and AI/ML-based activities for all products and services. 
  • Partner with regulatory and contribute to software sections of pre-submissions, and other premarket submissions for FDA and other health authorities.
  • Work with Freenome team on software quality and validation strategies and their execution, especially in support of AI/ML and software components.
  • Provide guidance to Freenome’s engineering and automation teams regarding 21 CFR Part 11 compliance.
  • Partner with Freenome’s regulatory team on FDA policy issues related to AI/ML and digital health. 
  • Partner with SW Development on establishing SW deliverables in accordance with regulatory requirements and industry best practices.
  • Partner with information security on issues regarding cybersecurity.  
  • Support risk management for software both in pre-market and post market capacity. 
  • Provide support during inspections and audits, for issues relating to software validation, 21 CFR Part 11 compliance, and other software issues. 
  • Provide guidance regarding change control management for software embedded in or supporting regulated devices.

Your background, perspective and experience:

  • BS degree in Life Sciences or Engineering.
  • Energetic expert in IEC 62304 and GAMP5.
  • Well-versed in ISO 13485:2016 and 21CFR820.
  • Proven track record of building and implementing Quality processes for software teams.
  • Proven track record of participating/leading software development initiatives from concept to market.
  • Positive and dynamic servant-leader who can both strategically lead teams and roll up sleeves to complete tasks.
  • 7+ years in a regulated life sciences company.
  • 2+ years of experience managing direct reports.
  • 2+ years of formal or informal experience in project management.
  • Experience with in vitro diagnostic devices (IVD).
  • Experience with Software as a Medical Device (SaMD).
  • Experience with Artificial Intelligence/Machine Learning.

 

COVID safety:

As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy.  If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster.  If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.

 

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

 

Funding

We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. 

 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

 

Benefits include but are not limited to:

  • Competitive compensation 
  • Pre-IPO equity
  • Flexible PTO (exempt) and generous PTO (non-exempt) 
  • Comprehensive health coverage, including medical, dental, and vision 
  • Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
  • 401(k) plan 
  • $250.00 new hire stipend to enhance your home office experience
  • Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts 

# # # 

Applicants have rights under Federal Employment Laws.  

 

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.  Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee. 

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. 

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you. 

 

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#LI-Remote, #LI-Onsite, #LI-Hybrid

Company

Mission

Freenome is a high growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.

Approach

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas. 

Funding

We have raised more than $1.1B from leading investors including Andreessen Horowitz, Bain Capital, GV, Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Novartis, Verily, and more. 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

 

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Find Us
Website
Phone
(650) 446-6630
Location
279 East Grand Avenue
5th Floor
South San Francisco
California
94080
US
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