Compliance Director

About Verantos

Verantos is a leader in high accuracy real world evidence (RWE) generation. The Verantos RWE platform integrates heterogenous real world data sources and generates evidence with the accuracy necessary for regulatory and reimbursement use. The Verantos RWE platform leverages data science and artificial intelligence along with advanced data sources such as electronic health records (EHR) to generate RWE capable of supporting clinical assertions.

Position summary

Verantos is looking for an individual who can implement a scalable compliance and quality assurance program for life sciences software solutions. This is an opportunity to be a leader of the company’s compliance function and to build a world-class organization focused on rigorous processes.

Responsibilities

  • Establish Verantos’ quality management system (QMS).
  • Work with executive management, product, engineering, quality control, and operations to implement compliance and quality assurance.
  • Work with stakeholders to develop standard operating procedures (SOPs).
  • Work with stakeholders to develop validation processes.
  • Achieve certifications such as ISO 9001 and HITRUST. 
  • Conduct internal audits to ensure compliance.
  • Lead external audits with customers.

Qualifications

  • Expertise in standards such as Title 21 CFR part 11, ISO 9001 etc.
  • 5+ years of experience working in reputed life sciences quality organizations, with increasing responsibility.
  • Experience in building and maintaining QMS.
  • Familiarity with QMS vendors.
  • Bachelor’s degree in a quantitative field from a reputed institution. Graduate degree preferred.

Please submit your resume below