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 degreepreferred
- 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%