Full-Time

Technical Compliance Manager

Confirmed live in the last 24 hours

OM1

OM1

51-200 employees

Health data analytics and AI technology platforms

AI & Machine Learning
Data & Analytics

Senior

Remote in USA

Required Skills
Communications
Requirements
  • BS Degree in Life Science or a technical discipline
  • 10+ years of relevant FDA regulated industry experience
  • 8+ years of direct experience conducting system validations within GXP environments
  • 5+ years of direct experience in a quality or compliance role
  • Experience writing system and process validation plans and reports
  • Clear understanding of GAMP 5 and Software Development Life Cycle (SDLC)
  • Experience in testing application in Agile/Scrum development process
  • Experience in all aspects of software testing life cycle (STLC)
  • Experience in writing SOPs and working instructions
  • Proactive identification and resolution of technical compliance issues
  • Excellent oral and written communication
Responsibilities
  • Manage validation program
  • Manage technical compliance processes
  • Serve as the Subject Matter Expert on validation and technical compliance
  • Collaborate with engineering teams to develop validation deliverables
  • Maintain knowledge of FDA GxP and Real World Data regulations
  • Provide assistance in writing/reviewing QMS documentation
  • Develop and deliver training on technical compliance processes
  • Assist in hosting Sponsor Audits and Regulatory Inspections
  • Perform other assigned duties

OM1 specializes in leveraging extensive clinical networks and industry-leading artificial intelligence to develop large, electronically-connected networks of health data in various specialty areas, offering enriched healthcare datasets and advanced platforms for real-world studies and personalized medicine solutions. The company's technologies include AI and predictive medicine, real-world data analytics, and custom data cohorts.

Company Stage

Series D

Total Funding

$176.3M

Headquarters

Boston, Massachusetts

Founded

2015

Growth & Insights
Headcount

6 month growth

4%

1 year growth

0%

2 year growth

-3%