QA Lead, Regulatory Compliance & Audits

CareDx, Inc.; United States; On-site; USD 112,000 - 140,000; Full time

Benefits offered by this job

Competitive base salary

Incentive compensation

Health and welfare benefits

Gym reimbursement

401(k) match

Employee Stock Purchase Plan

Pre-tax commuter benefits

Job summary

CareDx, Inc. is seeking a QA Lead to drive quality excellence across functions, ensuring compliance with CLIA, FDA, and GCLP while supporting the growth of our transplant-focused portfolio.

You will promote continuous improvement, work with cross-functional teams, and provide Design Control guidance for Laboratory Developed Test (LDT) services, embedding quality throughout the product lifecycle.

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.

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

Skills

Quality Assurance

Regulatory Compliance

Audits

Cross-functional Collaboration

Problem Solving

Education

Bachelor of Science in scientific field

Tools

Excel

Word

PowerPoint

Job description

CareDx, Inc. is seeking a QA Lead to drive quality excellence across functions, ensuring compliance with CLIA, FDA, and GCLP while supporting the growth of our transplant-focused portfolio.

You will promote continuous improvement, work with cross-functional teams, and provide Design Control guidance for Laboratory Developed Test (LDT) services, embedding quality throughout the product lifecycle.