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Director, Quality Systems

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, Quality Systems will support the company’s quality management activities which are compliant to various quality system requirements, such as the FDA, ISO 13485, and CLIA/CAP, as appropriate. You will join a high impact team that supports development of assays utilizing genomics and immunoassay technologies, and incorporating AI/ML algorithms, as part of a blood-based early cancer detection assay.  If you are passionate about quality systems, and want to be part of a team that will contribute to better early cancer detection tools, come talk to us!

Your contribution:

  • Responsible for development and continuous improvement of quality systems for products that will be regulated by the FDA.
  • Represent Quality Assurance at cross functional meetings and serve as the subject matter expert for quality system requirements for technical teams.
  • Oversee and lead processes such as document control, training, supplier management, internal audits, non-conformance management, and change control.
  • Ensure quality document and records (e.g., SOPs, worksheets, validations, event logs, and CAPAs) are reviewed and approved in a timely manner.
  • Perform and document internal audits and lead efforts to address findings.
  • Assist in interactions with, submissions to, and inspection preparations for the FDA, CLIA/CAP, NYSDOH, and international agencies as appropriate.
  • Assist in ensuring compliance with the FDA Quality System Regulations (21 CFR Part 820), the European in Vitro DiagnosticDirectives/regulations, ISO 13485 and other International Quality Standards as appropriate.

Your background, perspective and experience: 

  • At least 5 years leading a quality system compliant with FDA Quality System Regulations, and experience building new quality systems.
  • At least 5 years of experience in some combination of a molecular testing laboratory, a diagnostic manufacturing organization and/or a diagnostics service organization working in quality assurance department engaged in submissions to the FDA.
  • Excellent oral and written presentation and communication skills.
  • Bachelor and/or advanced degree in a life science discipline such as chemistry or biology, with some education in genetics.
  • Experience as a Director of the quality assurance function in an organization.
  • Experience with regulatory and quality system requirements for laboratory-developed tests.

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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