CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
As the Quality Assurance (QA) Lead, you will partner across multiple functions to drive quality excellence, ensure compliance with applicable quality system regulations and software standards, and support the continued growth of CareDx's product portfolio.
This highly collaborative role is responsible for implementing and maintaining quality system processes that support CLIA, FDA, and GCLP regulatory requirements. The QA Lead will work closely with cross-functional teams, field personnel, and colleagues across CareDx sites to promote quality compliance, continuous improvement, and operational excellence.
Success in this role requires strong problem-solving skills, the ability to work independently while thriving in a team-oriented environment, and a passion for partnering across departments to achieve shared goals. The QA Lead may also participate in cross-functional project teams and provide Design Control guidance for Laboratory Developed Test (LDT) services, helping ensure quality is embedded throughout the product lifecycle.
Responsibilities:
- Managing the electronic Quality Management System(EQMS) system to assure compliance to inhouse and/or external specifications and standards such as GMPs and CLIA. Includes basic system administrator responsibilities, creating new hire accounts, assigning training requirements, account terminations, training to users on how to use the EQMS, system maintenance such as periodic upgrades and troubleshooting
- Lead Quality System processes for Corrective/Preventive Actions, Supplier Corrective Actions, Supplier Qualifications, Complaints, Non-conforming Materials and Management reviews
- Manufacturing batch record reviews
- Quality review of procedures, forms, and other materials in collaboration with other departments
- Provide general guidance to personnel on quality requirements
- Support GCLP compliance and audits
- Participate in external and internal audits as needed
- Participate in development projects to support design controls and risk management processes
- Any other duty as assigned by QA department management
Qualifications:
- Bachelor of Science degree in scientific field is preferred with at least 5-8 years of related experience in Quality Assurance.
- General knowledge and understanding of FDA/QMSR and CLIA
- Experience in a CLIA-regulated laboratory environment and strong knowledge of Laboratory regulations desirable
- Experience with administrator responsibilities for commercially available document control databases strongly desired
- Experience with FDA, CLIA, CAP, NY State audits and inspections preferred
- Knowledgeable in supplier control and supplier monitoring
- Experience in performing internal and external quality audits
- Experience with PCR or RUO or IVD sequencing assays desirable
- Computer skills competency including Excel, Word and PowerPoint programs required
- Demonstrated ability to present to upper Management.
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package for US Employees includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits, including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy
The U.S. EEO posters are available here.
Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.
This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.
Skills Required
- 5-8 years of related Quality Assurance experience
- General knowledge and understanding of FDA/QMSR and CLIA
- Experience in a CLIA-regulated laboratory environment
- Experience with administrator responsibilities for document control / EQMS databases
- Experience with FDA, CLIA, CAP, NY State audits and inspections
- Knowledge of supplier control and supplier monitoring
- Experience performing internal and external quality audits
- Experience with PCR, RUO, or IVD sequencing assays
- Computer competency with Excel, Word, and PowerPoint
- Ability to present to upper management
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
