Senior Manager/Director of Quality

3 weeks ago

NouveauBrunswick, Canada HistoWiz Full time
HistoWiz is the largest online histopathology company, based in New York City. Our mission is to help biomedical researchers find cures by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving the public health. This position is accountable for the execution of assigned company GLP QA audit activities ensuring that the current regulations, policies, and procedures are adhered to at all of our Company sites (domestic and international) and at contract facilities worldwide.

Since inception in 2013, we have doubled our month-over-month sales, driven primarily by customer referrals. We are profitable, won numerous awards and are funded by prestigious investors, including Y-Combinator and Zhenfund. We are seasoned scientists with experience at leading academic institutions and have published high impact research in top journals of biomedicine.

HistoWiz has over 1,000 paying customers globally from top academic institutions (e.g. MSKCC, Harvard, Stanford, HHMI) and pharmaceutical companies (e.g. CRISPR, Johnson & Johnson, Regeneron). We process tissue specimens and digitize all of the results, hosting our client's data on a proprietary platform, PathologyMapTM . This platform not only enables industry-leading turnaround time for diagnosis, but also online viewing, sharing and search. No other platform like this exists, so we are truly building something new that can bridge scientists, doctors, and patients from all over the world to conquer life-threatening diseases collaboratively instead of individually. This online platform also contains the world's largest collection of pathology data and the first network of top pathologists. Today, we are expanding our laboratory services into GLP to support our customers' growing histology needs.

Who are you?

The Senior Manager/Director of Quality is responsible for overseeing the quality and compliance of laboratory operations with GLP/GCLP regulations. Supports the laboratory with the build out of the quality systems necessary to run a GLP lab operation. Oversees the development, implementation, and maintenance of the quality management system in accordance with the GLPs. Leads internal audits and hosts client audits. Responds to client questionnaires and inquiries. Duties carried out in accordance with the HistoWiz QMS and Standard Operating Procedures (SOPs) to support GLP and non-GLP work. Additional experience with CAP/CLIA a plus. We are looking for a critical member of the team that aims to build from the ground up, not just audit.

GENERAL RESPONSIBILITIES AND SPECIFIC DUTIES
  • Develop, review and update SOPs and BOPs.
  • Provide guidance and technical support to laboratory staff on GLP regulations.
  • Train staff on the GLPs and GLP compliance.
  • Maintain and ensure GLP compliance for staff training files, master schedule, etc.
  • Lead internal audits in support of GLP studies, writing inspection reports, following up on observations, ensure timely corrective actions are taken on any findings.
  • Prepare QA statements for GLP study reports.
  • Prepare laboratory and staff for GCLP
  • Ensure sponsor inspection readiness.
  • Host client audits, prepare internal team, and manage follow-up with external auditors.
  • Work collaboratively with staff responding to and resolving deviations and audit observations.
  • Follow through on corrective and preventative actions from deviations and audit observations
  • Control SOP writing, reviewing, approving and distributing.
  • Working with the Laboratory Management team to achieve company goals.
  • Lead QA unit and develop junior QA associates within the team, in a dynamic startup environment
Requirements
  • A BS and/or MS degree in a scientific or technical field
  • At least 5 years of experience in Quality Assurance working at a CRO, pharma, biotech or diagnostic lab
  • Prior audit and GLP review experience
  • In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance)
  • Excellent communication skills and work well under pressure in a team environment

Additional Experience:

  • Experience in histology, histotechnology, and IHC are highly desirable.
  • Lab management experience is a plus.
Benefits

We believe in investing in our employees' professional development and encourage networking within the bioscience, tech, and startup communities for all our employees and collaborators. Compensation is top-notch, and stock options are available for outstanding employees, commensurate with the impact you have within our organization and for the scientific community overall. In addition, we provide the time and freedom to pursue independent projects.
  • 100% coverage on employee health, vision, and dental insurance, partial coverage for family
  • Memberships to TeleDoc and TalkSpace (one year)
  • Parental leave
  • NY Commuter benefits
  • Flexible Spending Accounts (FSA) and Health Savings Account (HSA)
  • Retirement planning (401k)
  • Onsite gym membership and commuter showers
  • Team building events outside the office
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