Quality Assurance Manager

About BOSTONGENE

BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision-making in the fight against cancer. Our unique solution continuously aggregates the latest cancer research and clinical information from around the world. BostonGene’s unique solution performs sophisticated analytics to aid clinicians in their evaluation of viable treatment options for each patient’s individual genetics, tumor and tumor microenvironment, clinical characteristics, and disease profile. BostonGene’s mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and integration of scientific and clinical knowledge.

Position Summary

The Quality Assurance Manager is responsible for oversight and management of the day-to-day operations of the QA department. The role is responsible for the implementation, maintenance and continuous improvement of the laboratory Quality Management System per ISO, FDA, and other regulatory agencies and for ensuring that laboratory testing is performed in compliance with all applicable regulations and certifications, including, but not limited to, CAP, NYSDOH, and CLIA. . The role works closely across all levels of a highly motivated and collaborative organization to ensure quality and timely execution of quality requirements, adhering to compliance and safety standards while ensuring a patient-focused mindset.

Responsibilities

  • Responsible for the implementation and efficient management of quality management systems (QMS) to various US and international regulatory requirements.
  • Develop quality metrics across all QMS processes, and implement data-driven approach to quality management.
  • Apply quality management best practices and innovation to ensure QMS is built around value-based and efficient principles in ensuring regulatory compliance.
  • Work closely with cross-functional stakeholders to ensure QMS incorporates the organizational needs and those of internal (as much as external and regulatory) customers, is closely integrated with the business processes, and is aligned with the technological needs
  • Report to laboratory management on the performance of the quality management system, and any need for improvement. Guide the organization on strategy and implementation of continuous improvement of the quality management system. Perform Quality Assurance planning.
  • Direct, advocate, and enable visibility of quality processes. Ensure accountability within all phases of patient testing (pre-analytical, analytical and post-analytical).
  • Direct, advocate, and enable visibility of quality processes. Ensure accountability within all phases of patient testing (pre-analytical, analytical and post-analytical).
  • Ensure compliance with all pertinent regulatory standards including those of CLIA, Commonwealth of Massachusetts, CAP, GCLP, NYSDOH and the states of NY, MD, RI, CA, and PA.
  • Provide effective leadership for activities necessary to ensure communication, training, competency assessment, and ongoing compliance monitoring within the laboratory’s quality management system
  • Direct programs or procedures which assure compliance with all regulations, timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
  • Be a resource to the company when there is a need for document review and compliance assessment. 
  • Establish and maintain collaborative relationships with key stakeholders.
  • Provide guidance to BostonGene departments on CAPA and nonconformance investigations including leading the QA investigation team. Conduct root cause analysis and implementation of corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
  • Establish and maintain a robust Document Control system and Change Control.
  • Host internal and external audits and assume all responsibilities pertaining to external regulatory bodies. Maintain excellent positive relationships with auditors or regulatory agencies.
  • Act as a manager of quality professionals; ensure activities are completed in alignment with goals and ensure continuous development of personnel.
  • Perform other related duties and responsibilities as assigned

Qualifications

  • Bachelor’s Degree in a relevant life science discipline
  • 5+ years’ experience in a Quality/Regulatory environment, with proven experience developing Quality Management System and audit management in some combination of a diagnostic manufacturing organization (IVDs) and molecular testing laboratory (LDTs)
  • Demonstrated experience in regulatory compliance and developing new quality policies and procedures.
  • Advanced Degree in the Sciences, Engineering, Business, or a related field
  • ASCP or MT(AMT) Certification
  • ASQ Certification
  • Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
  • Evidence of knowledge of molecular biology
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Strong skills in troubleshooting and problem solving
  • Highly organized with strong attention to detail
  • Understanding of HIPAA and importance of privacy of patient data
  • Experience with CDx (Companion Diagnostics) and NGS technologies a plus
  • Experience with GCLP (Good Clinical Laboratory Practices) QMS requirements a plus
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