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 of technical compliance processes. This role will manage the validation program and partner closely with the 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 at OM1
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
Collaborate with the engineering teams to develop validation deliverables including, but not limited to, risk assessments, validation plans, user requirements, test cases, summary reports, change control, and periodic reviews throughout the system life cycle
Maintain an excellent knowledge of FDA GxP (Good Practices) 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 technical compliance processes, regulatory compliance, and quality-related topics
Assist the Director of Compliance in hosting Sponsor Audits and Regulatory Inspections and Serve as validation Subject Matter Expert (SME)
Perform other duties as assigned.
What Experience You'll Bring
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
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 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 in writing SOPs and working instructions
Proactive identification and resolution of technical compliance issues
Excellent oral and written communication
What's 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 in CAPA
Experience with conducting internal and external audits and regulatory inspections
Familiarity with RWD/RWE
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.
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