About Human Longevity Inc.
Human Longevity Inc. (HLI) is the genomics-based, technology-driven company creating the most comprehensive database of whole genome, phenotype and clinical data. HLI is developing and applying large scale computing and machine learning to make novel discoveries to revolutionize the practice of medicine. A privately held company headquartered in San Diego, CA, HLI was founded in 2013 by pioneers in the fields of genomics and stem cell therapy. HLI will be licensing access to its database, and developing new diagnostics and therapeutics as part of their product offerings. For more information, please visit www.humanlongevity.com.
Purpose of Job
The person occupying this position will take responsibility for helping to develop and maintain the 21 CFR part 820 Quality Management System (QMS) infrastructure to comply with FDA requirements to support new products and associated regulatory submissions. This position will help to develop and oversee the QMS in all areas for compliance, 510k and/or de novo submissions, audit readiness and quality of services. This position will report to the Head of Quality and Regulatory Affairs, but works closely with the technology team, bioinformatics scientists, clinicians, machine learning scientists, product managers and software engineers developing and implementing imaging post processing software and workflows.
The Software Quality Manager is responsible for the overall administration of the Quality Management System to support and ensure compliance with applicable regulations for new products. This position will also be responsible for implementation of QMS policies, including design control, to support business operations and regulatory compliance. The high complexity nature of the work requires excellent attention to detail, effective written, ability to self-direct, verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work independently in a team environment.
Tasks and Responsibilities
- Establish and maintain systems and non-technical policies and procedures to ensure product quality and compliance. Ensure appropriate documentation is maintained for compliance (Design history file, Device master record, Device history record, etc).
- Revise Software Development Lifecycle policy to comply with 21 CFR part 820 and ISO 13485
- Lead the core team to ensure that company priorities, regulatory/accreditation requirements and timelines are met.
- Oversee the design and implementation of validation procedures, test plans, and test cases.
- Developing, write and manage the execution of an overall software test strategy as required.
- Review completed validations to ensure they meet FDA and other applicable requirements.
- Help to maintain site licenses for the facility and ensure renewal of licenses as required. Coordinate inspection activities including compliance with FDA.
- Serve as liaison with regulatory agencies.
- Ensure that documents and records are reviewed and approved in compliance with regulations and organizational policy.
- Ensures proper evaluation, timeliness and completeness of investigations, root cause analysis as well as corrective and preventive actions (CAPA).
- Oversee nonconforming event management system including tracking timely resolution of events through corrective/preventive action.
- Train personnel on Quality System policy and procedures.
- Lead Management Review meetings as required.
- Develop and oversee Quality metrics collection, reporting and analysis.
- Develop and present Quality training to all levels of staff
- Identify, track and carry out Quality Improvement initiatives
- Develop schedule and lead internal audit teams with appropriate expertise for scope of audit in all areas to identify areas for improvement and ensure ongoing compliance. Deliver audit findings and provide recommendations for improvement.
- Perform or participate in vendor or sponsor audits, site visits and evaluations as necessary
- Participate in implementation of compliance software to include document control, nonconforming event management, and change control modules
- Serve as document controller for FDA related policies and ensure compliance with organizational policy/regulatory requirements.
- Supports, consults, trains and leads quality improvement projects throughout the product/process life cycle.
- Manages customer complaint investigation management and supplier quality processes.
- Work to ensure compliance with current applicable regulatory requirements.
- Present to Executive Leadership as necessary
- Foster a culture of compliance and quality
- Serve as consultant for medical device related regulatory and QMS matters
Minimum Qualifications (Must have)
- Minimum 3 years Quality Management experience in FDA regulated environment (medical device preferred) with a focus on software.
- Experience in establishing 21 CFR part 820 compliant and ISO 13485 conformant Quality Systems.
- Demonstrated expertise to effectively communicate within all levels of the organization around regulatory requirements and concepts of quality management, including, internal audit, change management, document control, nonconforming event management including Corrective & Preventive Action (CAPA), etc.
- Possess working knowledge of applicable local, state and federal regulations.
- Candidate should have prior management experience or demonstrate leadership through previously held positions in which the candidate had supervisory responsibilities.
- Experience in a start-up environment
- Dynamic individual with the ability to communicate and engage others
- Software experience prior to quality/regulatory experience preferred.
- Experience implementing compliance/Quality Management System software highly preferred.
- Experience with imaging post processing software, in radiology field and/or machine learning highly desired.
- 510k and/or de novo submission experience for software as a medical device
- Mixture of private offices, open space with cubicles, and wet-bench laboratory and storage facilities
- May require work beyond standard business hours
- Prolonged periods of sitting, standing, bending and kneeling
- Ability to walk, travel up and down stairs, crouch, stoop and reach.
- Must be able to lift and transport at least 25 pounds