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Quality Assurance Director – Clinical Laboratory

Are you looking for an opportunity to bring your proven expertise in Quality Assurance to support the development of a brand-new state-of-the-art Oncology Molecular testing lab for clinical trials as well as Standard-of-Care?
Do you want to be one of the first employees in a new venture, where you will play an active role in setting the standards and framework for an exceptional quality-oriented organization?
Do you have what it takes to prepare the new lab for its very first full client audit and recurring CLIA/CAP inspection?
Do you want to lead the QA function through the full lifecycle of development, spearheading the combined clinical trials and standard-of-care capability?
Are you ready to bring your skills and experience and can grow under the guidance of leaders with extensive Quality and FDA experience, in an environment that fosters ideas and collaboration?

If your answer to these questions is an emphatic “yes” and you are ready to help lead an established segment leader, with an exceptional reputation in diagnostic testing drives a strategic expansion into genomic sequencing for Oncology, we need to hear from you.

@Orchard LLC has been asked to assist a firm already known for exceptional capabilities in the areas of diagnostic testing as they embark on a new venture and expansion. Our client has created a new Biosciences Division and is building a state-of-the-art lab in New Jersey to provide specialized genomic and molecular pathology (MP) contract services for biopharma as well as for standard-of-care patient testing. The services provided will assist in the research, development, and commercialization of new products for companies in the pharmaceutical and biotechnology space, with an emphasis on Oncology.

In support of the highly advanced genomics and MP services, our client is developing a turnkey offering for biopharma clients with central lab work, including sample kitting and logistics management for clinical trials. Critical to the success and long-term viability of the lab will be its approach to Quality Assurance, and our client is committed to developing a best-in-class function, starting with hiring a Director of Quality Assurance to establish the QA/QMS plan.

If you have been looking for an opportunity to put your Quality Assurance experience to the test and always wanted to set a QA function up from the start to be a bell-weather standard for excellence, while working with some of the smartest people in the field of NGS, Molecular and Oncology testing, then we need to hear from you. Our client’s facility is located just outside Princeton, NJ, and will provide an exceptional working environment from a firm already recognized as a Top Place to Work.

As the Director of Quality Assurance, you will.
Report directly to the Chief Scientific Officer and work closely with the senior/executive team while establishing the core QA plan and regulatory compliance environment for the new Laboratory, as well as the emerging Standard-of-Care capability already in place.

Working 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, CAP, NYSDOH, and FDA (whenever applicable) guidance and standards. You will ensure that quality standards are being met and that 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 laws and regulations that are required by CLIA, CAP, OSHA and NYSDOH, and any other applicable legislative organizations, and raise any related issues to upper management in real-time. The Quality Assurance Director will oversee a QA team and work cooperatively to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready at any moment.

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 the QA team and function cross-functionally, while ensuring QMS areas are adequately supported and resourced.
  • Partner with the lab director(s) and other stakeholders to develop and implement policies and procedures and train lab staff on them.
  • Maintain company compliance to CAP/CLIA regulations 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 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 Ph.D. in Life Science, Medical Technology, Chemistry, or Engineering.
  • NYS CLT License (preferred).
  • 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.
  • Demonstrate a focus on ensuring continuous monitoring and process improvement to build collaborative efficiencies.
  • Provide examples of building a culture of solution-oriented and evidence-based mindsets with openness to 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

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