Quality Assurance Manager (NY)

28th January 2021
Vandu Worldwide

Our Client is building a platform to power novel scientific insights through characterizing and measuring the immune system. The Company is building the world’s largest multi-omic immune database by combining cutting-edge single cell sequencing technologies with advanced machine learning methods. The platform will create value to the biopharma industry and academic researchers by guiding critical decisions in drug discovery and clinical trial design.

We are seeking a highly motivated individual to join a team of talented scientists and engineers in a highly collaborative startup environment at the intersection of Immunology, AI and new genomic technologies. This position offers an opportunity to work with state-of-the art genomic technologies on a diverse set of projects related to human cancer immunology and autoimmunity. The successful candidate will design, implement and maintain a robust QA programme, collaborating closely with the scientific, operations and computational teams. The successful candidate will be responsible for ensuring compliance with relevant regulatory programme, and lead both the strategy and tactics of a QA programme that supports the business goals.

Key Responsibilities

  • Implement a program that promotes quality across the enterprise and following work portfolios;
    • Next Generation Sequencing
    • Genomic Assays
    • Accessioning processes
    • Sample Management
    • Incoming inspections
    • CLIA
  • Lead Quality Management System development and implementation
  • Lead ongoing development and execution of QMS including strategy and policy
  • Establish ongoing training for colleagues on QMS and Document Control System
  • Lead activities to maintain compliance with contractual and legal obligations
  • Manage the preparation for external inspections by accreditation and certification agencies
  • Review, approve and manage compliant standard operating procedures (SOPs)
  • Perform and manage audits of internal processes and systems
  • Ensure that quality activities and records are in compliance with SOPs and regulatory requirements; ensure proper documentation of quality activities
  • Report on quality metrics, corrective and preventive action status, internal/external audit results
  • Responsible for assuring that corrective actions and preventive actions are established, tracked trended and proved effective
  • Work with the IT team and regulatory affairs manager in the development and implementation of compliant biorepository data collection and specimen management systems
  • Responsible for company compliance with regulations regarding equipment, instrumentation, safety, security and monitoring systems
  • Perform as internal and external liaison communicating Quality Control (QC) strategies, tactics, and requirements
  • Provide guidance and interpretation of quality standard requirements for functional areas
  • In association with regulatory affairs, ensure policies and procedures are compliant with ethical standards for human tissue use as defined by regulatory agencies
  • Stay abreast of changes in quality standards, regulations, quality metrics, and audit techniques

Requirements

●       BS degree in a Life Sciences or related field required

●       Relevant experience in Life Science Quality Assurance Management. Experience in Six Sigma or LEAN preferred

  • Experience in QMS design, implementation and maintenance

●       Familiarity with NGS preferred

  • Experience with achieving & maintaining regulatory compliance (e.g. GLP / GCP, CLIA, CAP)

●       Strong analytical skills, problem solving ability, and innovation aptitude required

●       Must be willing to discover and learn new software and technology applications quickly

●       Must have strong attention to detail and multi-tasking skills

●       Excellent interpersonal skills and ability to effectively work across a multidisciplinary team

 

Facility

The Laboratory is located within BioLabs@NYU Langone incubator. Staff enjoy access to state-of-the-art laboratory facilities and equipment, café, meeting rooms, lounge, and a plethora of restaurants and shopping in and around Hudson Square neighborhood of Manhattan.