The Quality Assurance Manager is responsible for executing the company’s Quality strategy and policies. This position reports to the Director of Quality and ensures quality compliance for validation, CAPA, and continuous improvement activities.
HealthTell is now a central part of iCarbonX’s Digital Life Alliance along with Cambridge, MA based PatientsLikeMe; this represents an unprecedented ecosystem of leading bio, health networking, sequencing and artificial intelligence technology companies.
This position is based in Chandler, Arizona but may support other company and Alliance partner locations as needed.
- Quality Lead for manufacturing validation efforts, CAPA and continuous improvement activities.
- Provides GMP regulatory compliance guidance (FDA, EU & HC) for GMP operations.
- Collaborates with Manufacturing, and other departments to implement quality strategies.
- Manages Quality activities as they relate to investigations, risk management, etc.
- Other duties as required
- Bachelor’s degree in bioengineering or related field; advanced degree preferred
- 5+ years of experience in a biotech company leading quality systems.
- Proven GMP knowledge
- Working knowledge of ISO 13485:2016 and FDA 21 CFR: Quality System Regulation
- Proven ability to work effectively with Manufacturing and other functional groups.
- Strong scientific, problem solving and analytical acumen in engineering or biochemistry.
- Proven Risk Management skills
- Statistical knowledge a plus
- Certified Lead auditor accreditation a plus
- Strong project management skills with an emphasis on critical thinking and problem solving
- Proven written and verbal communication skills
- Can travel domestically, up to 5%
About iCarbonX Digital Life Alliance
HealthTell is now a central part of iCarbonX’s Digital Life Alliance; this represents an unprecedented ecosystem of leading bio, health networking, sequencing and artificial intelligence technology companies. The alliance is working to combine biological and patient generated data with artificial intelligence technology to more rapidly detect meaningful signals about health, disease and aging, deliver a personalized guide for living a healthy life, and help industry learn even more about how to improve outcomes, and lives.
HealthTell is a well-funded Life Sciences company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, and monitoring progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images. The ImmunoSignature™ Test will enable physicians to detect disease at an early stage, resulting in improved outcomes and reduced healthcare expenditures.
HealthTell is an equal opportunity employer.