Technical Compliance Manager

4 weeks ago

Boston, United States OM1 Full time

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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