Supplier Quality Specialist II

Why join Freenome?

Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. 

Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. 

Founded in 2014, Freenome has ~500 employees and more than $1.1B in funding from key investors, such as the American Cancer Society, Andreessen Horowitz, Anthem Blue Cross, Bain Capital, Colorectal Cancer Alliance, DCVC, Fidelity, Google Ventures, Kaiser Permanente, Novartis, Perceptive Advisors, RA Capital, Roche, Sands Capital, T. Rowe Price, and Verily.  

At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count. 

Become a Freenomer

Do you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.

About this opportunity:

At Freenome, we are seeking a Supplier Quality Specialist II to help grow the Freenome Quality Assurance team. You will play an integral role supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This role will also support Freenome’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements. This position will also facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification) and support the quality assurance activities in partner development as needed. You will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer. The role reports to the Director, Quality Systems, with indirect oversight and guidance provided by our Senior Supplier Quality Engineer.

What you’ll do:

• Maintain the approved supplier list and supplier audit schedule
• Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
• Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement
• Monitor quality agreements with critical suppliers, and quality of supplier records
• Actively participates in supplier quality related communication and feedback
• Work with the Clinical Quality team to support qualifications for clinical vendors 
• Support establishing quality agreements and processing supplier change. notifications
• Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received
• Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments
• Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
• Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

Must haves:

• Minimum of a Bachelor's degree in a life science (genetics or molecular biology preferred) or equivalent experience
• 2+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality
• Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
• Ability to prioritize and multitask while maintaining a positive and collaborative attitude
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
• Flexibility to successfully balance and prioritize multiple ongoing projects/tasks. in a fast-paced, deadline driven environment
• Drive for results and continual improvement
• Travel 0 - 10% domestically and potentially internationally

Nice to haves:

• ISO 13485 certified Lead Auditor
• Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma
• Experience with internal audits or external audits
• Experience with statistical process control (SPC) techniques to evaluate and improve process performance

Benefits and additional information:

The US target range of our base salary for new hires is $78,625 - $120,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ https://careers.freenome.com/ for additional company information.  

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.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

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