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Technical Compliance Manager



IT, Legal
Boston, MA, USA
Posted on Wednesday, August 16, 2023
OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics to transform records from a diverse set of sources into enriched, research grade data which allows us to generate unique insights in a variety of disease areas.
This role will be responsible for the management technical compliance processes. This role will manage the validation program and partner closely with the products and engineering teams to ensure systems are in alignment with regulatory expectations.
The position will entail building strong cross-functional relationships throughout the organization. This role will also contribute to Training, Audit, Document Control, Quality (QA) / Compliance Support, Corrective Actions and Preventive Actions (CAPA), Vendor Management, and additional responsibilities consistent with the entrepreneurial spirit of OM1.

What You'll Do

  • Manage validation program
  • Manage technical compliance processes
  • Serve as the Subject Matter Expert on validation and technical compliance directly supporting and providing assistance to OM1 staff, related to all disciplines of Quality Management Systems (QMS), with an emphasis on Technical Compliance
  • Review and provide technical guidance to assure compliance with regulations and internal processes for : Validation Plans and Reports, User Requirements Specifications (URS) and System Requirement Specifications (SRS)
  • Independently schedule, plan, and perform internal and external audits; including, but not limited to: process (general or project/study-specific), vendor, electronic trial master files (eTMF), etc.
  • Maintain an excellent knowledge of FDA GCP and Real World Data / Real World Evidence (RWD/RWE) regulations
  • Provide assistance to various departments in writing / reviewing QMS documentation (SOPs/WIs) to assure compliance with regulations and internal processes Develop and deliver training on OM1 processes, regulatory compliance, and quality-related topics, with an emphasis on technical compliance
  • Assist the Director of Compliance in hosting Sponsor Audits and Regulatory Inspections
  • Maintain an excellent knowledge of FDA GCP and Real World Data / Real World Evidence (RWD/RWE) regulations

What Experience You'll Bring

  • BS Degree in Life Science or a technical discipline
  • 8+ years of relevant FDA regulated industry experience
  • 4+ years of direct experience conducting system validations within GXP environments
  • 3+ years of direct experience in a quality or compliance role
  • Experience writing system and process validation plans and reports
  • A clear understanding of GAMP 5 and Software Development Life Cycle (SDLC) - including analysis, system and user testing, and problem resolution
  • Experience in testing application in WaterFall or Agile /Scrum development process Experience in all aspects of software testing life cycle (STLC) such as test plan preparation, test script preparation, test execution, defect reporting and tracking
  • Experience with conducting internal and external audits
  • Experience in writing SOPs and working instructions
  • Proactive identification and resolution of technical compliance issues
  • Excellent oral and written communication

What is Nice to Have

  • Familiarity with the following is preferred: Electronic Data Capture (EDC), eTMF, Google Suite, AWS, Cloud Storage & Security, Infrastructure as Code/Terraform, GitHub, SQL, and Python
  • Experience in Test Automation Tools or Application Lifecycle Management (ALM)Experience in Black Box Testing, Graphical User Interface (GUI) Testing, User Acceptance Testing, Database Testing, System, Functional, and Regression Testing
  • Experience participating in Sponsor Audits and Regulatory Inspections
  • Experience with producing and presenting training presentations Experience in CAPA Familiarity with RWD/RWE
If you’re excited about this role but your past experience doesn’t align perfectly with every qualification, we encourage you to apply anyway. You may be just the right candidate for this or other roles.
OM1 is an equal employment opportunity employer and considers qualified applicants without regard to gender, sexual orientation, gender identity, religion, race, veteran or disability status. At OM1 ensuring that people feel respected, valued, and included is essential to our success. We are committed to working together to provide a work environment that embraces the principles of diversity, equity, and inclusion.