Acutis Diagnostics is a growing clinical laboratory with locations in Hicksville, NY and Monmouth Junction, NJ. We pride ourselves on providing expert, accurate and concise results as a product of our highly talented and passionate team of professionals. We believe the team we build today will be the foundation of our future success.
The Director of Quality Assurance will report directly to the Chief Scientific Officer and work closely with senior/executive team while establishing the core QA plan and regulatory compliance environment for the new Laboratory located in NJ, as well as the Standard-of-Care capability already in place in NY. The Director will be working from the NJ location but manage the NY lab QA and staff with frequent visits to NY as needed.
The Qa Director will oversee a QA team and work cooperatively with the lab technical, medical and operation director(s), lab manager(s) and supervisors to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready at any moment.
The Director of QA will work with the Clinical Laboratory Director(s), and will be responsible for creating and maintaining a quality plan and quality management system (QMS) which will be compliant with CLIA, COLA, CAP, NYSDOH, and FDA (whenever applicable) guidance and standards, and meet biopharma and medical device companies’ expectations.
The QA Director will ensure that quality standards are being met, and any deviation from an applicable protocol, standard or guideline has been adequately investigated and addressed. Provide QA expertise to the laboratory and, as needed, serve as the liaison to external governing entities. Ensure that the laboratory and the laboratory staff follow all applicable laws, regulations and standards, and raise any related issues to upper management in real time.
Key responsibilities and tasks will include:
Develop and implement a quality strategic plan for the Quality Management System (QMS) to successfully support lab developed tests (LDT) and FDA-approved IVD medical devices including software algorithms intended to provide patient information and support.
Provide leadership and mentorship for QA team and function cross-functionally, while ensuring QMS areas are adequately supported and resourced.
Partner with the lab director(s), mangers, supervisors and other stakeholders to develop and implement policies and procedures and train lab staff on them.
Maintain company compliance to CAP/CLIA regulations/standards for LDT, NYSDOH and other state regulations and 21 CFR 820 when applicable.
Monitor and improve internal and external customer satisfaction through Quality initiatives, establishing QA metrics and process improvement.
Collaborate closely and effectively with R&D and operations to ensure end to end oversight of Quality technical activities, including planning and findings review/mitigation.
Lead and support any internal, customer, regulatory body, or health authority audits/inspections.
Lead and support the compilation and articulation of non-conformances and the implementation of best-practice corrective action and preventive action plans (CAPAs) to bring any issue to resolution as quickly as possible.
Oversee and drive the refinement of training program requirements, document control and supplier quality activities to build in increased effectiveness.
Oversee training and education of Quality throughout the organization and build collaborative relationships with key stakeholders.
First lead the creation of a new Quality Plan, and then collaborate with the Clinical Laboratory Director, Director of Operations and Quality Team to optimize and enforce the Quality Plan as it is written.
Maintain a state of readiness for inspections, through regular periodic meetings with all department Directors and supervisors, self-inspection checklists and proactive observation.
Prioritize responsibilities, anticipate problems, and provide timely and appropriate solutions.