Share Email Opening Title Director of Quality Assurance   About the Organization Acutis (www.Acutis.com) is a specialized medical laboratory that complements its hard science with the soft skills of its support teams. This combination allows practitioners to diagnose and treat with greater confidence and with ease. Acutis serves the medical community and related fields by providing rapid, reliable diagnostic insights that impact clinical decisions in: -infectious disease -clinical toxicology for substance use testing and medication monitoring -oncology We are a biomedical specialty laboratory that has no tolerance for error. A company as thorough as it is principled: dedication to the advancement of medical testing, industry-leading turnaround time, and world-class service. Every sample we take and every report we relay is prepared with this end in mind: to provide our customers with the highest level of certainty possible. With a service-first mindset, specialized laboratory capabilities, and the agility to adapt as next-generation therapies evolve, Acutis stands at the Service of Science. Additionally, building on our platform of advanced science and technology, we have introduced to healthcare professionals to Acutis Reveal™, molecular tests for infectious diseases. These new tests offer physicians and clinicians a greater degree of certainty than any standard or traditional test can. These new products offer further evidence of Acutis' passion for innovative technologies and strategies. Acutis conducts pioneering research for diagnostic services. We employ NGS, targeted PCR, LC-MS/MS, enhanced microbiology techniques and algorithm-based software to develop new diagnostic solutions.   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description 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. As the Director of Quality Assurance, you 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. The director will be leading the QA department in the NJ location but will coordinate with the NY lab director and QA staff for transferring applicable SOPs/Policies. 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. Work with the Clinical Laboratory Director(s), you will be responsible for creating and maintaining a quality plan and quality management system (QMS) which will be compliant with CLIA, COLA, CAP, and FDA (whenever applicable) guidance and standards, and meet biopharma and medical device companies' expectations. 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), managers, supervisors, and other stakeholders to develop and implement policies and procedures and train lab staff on them. Maintain company compliance with CAP/CLIA regulations/standards for LDT, 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. Your background will include: BSc, MSc, or PhD in Life Science, Medical Technology, Chemistry or Engineering. At least 10 years of experience in Quality Assurance implementing and/or maintaining quality management systems in a regulated clinical laboratory or an IVD company. 5+ years of experience in a lab providing services to pharma and biotech companies in clinical trials. Demonstrated knowledge of all laws and regulations that are required by CLIA, CAP, OSHA and other related legislative and/or state health departments and organizations. Experience building and leading high performing teams, including direct-report managers. Demonstrated ability to interact with all levels of colleagues to educate and inform on the utility of the QMS, in turn driving compliance and continuous improvement. Examples demonstrating focus on ensuring continuous monitoring and process improvement to build collaborative efficiencies. Prior examples of building a culture of solution-oriented and evidence-based mind-sets with openness for innovative ways of working. Proven ability to lead cross-functional teams in problem-solving and execution. Excellent professional communication skills, including verbal, written, and presentation. Excellent collaboration skills, with the ability to positively influence others. Computer proficient with multiple software programs, including MS Office Suite, and Laboratory Management Systems. If you believe you have the experience above, the desire to participate in creating a new solution-set within the genomic sequencing space, one that marries the best from standards of care and biopharma, then, we are waiting to speak with you   Position Requirements Education requirement BSc, MSc, or PhD in life Science, medical technology, chemistry or engineering. NYS CLT License (preferred) 10+ years of experience in QA implementing and/or maintaining quality management systems in a regulated clinical laboratory or an IVD company. 5+ years of experience in a lab providing services to pharma and biotech companies in clinical trials. Experience and Skills Required Experience building and leading high performing teams, including direct-report managers. Ability to interact with all levels of colleagues to educate and inform on the utility the QMS, in turn driving compliance and continuous improvement. Ability to drive continuous monitoring and process improvement to build collaborative efficiencies. Ability to drive a culture of solution-oriented and evidence-based mind-sets with openness for innovative ways of working. Ability to lead cross-functional teams in problem-solving and execution. Experience in the areas of laboratory supervision and workflow needs and technical capabilities Experience working with Quality Management including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA and other related legislative and/or state health departments and organizations. Excellent professional communication skills, including verbal, written, and presentation Excellent collaboration skills, with the ability to positively influence others Computer proficient with multiple software programs, including MS Office Suite, and Laboratory Management Systems Must have willingness to travel to Hicksville, N.Y. on occasion. Ability to commute/relocate: Monmouth Junction, NJ 08852: Reliably commute or planning to relocate before starting work (Required) Education Requirements: Bachelor's (Required) Experience Requirements: QA/QC: 10 years (Required) Lab/ BioPharma: 5 years (Required)   Full-Time/Part-Time Full-Time   This position is currently not accepting applications. To search for an open position, please go to http://AcutisDiagnosticsInc.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category Director of QA in Monmouth Junction, New Jersey Posted on: 9/7/2023 [Apply Now] Other Jobs Within 60 Miles General Application in Hicksville, New York Posted on: 6/3/2022 [Apply Now] Director of QA in Monmouth Junction, New Jersey Posted on: 9/7/2023 [Apply Now] Specimen Accessioner in Hicksville, New York Posted on: 8/8/2023 [Apply Now] Research & Development Specialist II (Molecular) in Hicksville, New York Posted on: 9/7/2023 [Apply Now] Clinical Laboratory Technologist in Hicksville, New York Posted on: 9/7/2023 [Apply Now]

AppOne.comTM   ©1999-2021 HR Services, Inc. Click here for technical assistance.