- Manage the validation program
- Supervise technical compliance processes
- Act as the Subject Matter Expert on validation and technical compliance, offering support to OM1 staff on Quality Management Systems (QMS), with a focus on Technical Compliance
- Collaborate with engineering teams to create validation deliverables including risk assessments, plans, user requirements, test cases, reports, change control, and reviews throughout the system life cycle
- Maintain extensive knowledge of FDA GxP (Good Practices) and Real World Data / Real World Evidence (RWD/RWE) regulations
- Support various departments in drafting / reviewing QMS documentation (SOPs/WIs) to ensure compliance with regulations and internal processes
- Conduct training on OM1 technical compliance processes, regulatory compliance, and quality-related subjects
- Aid the Director of Compliance in hosting Sponsor Audits and Regulatory Inspections and act as a validation Subject Matter Expert (SME)
- Perform assigned tasks
- BS Degree in Life Science or a technical field
- Over 10 years of relevant FDA regulated industry experience
- More than 8 years of hands-on system validations within GXP environments
- Over 5 years of experience in a quality or compliance role
- Experience in creating system and process validation plans and reports
- Thorough understanding of GAMP 5 and Software Development Life Cycle (SDLC), encompassing analysis, testing, and issue resolution
- Experience in testing applications within Agile / Scrum development
- Familiarity with all aspects of the software testing life cycle (STLC) like test planning, script preparation, execution, defect reporting, and tracking
- Proficiency in writing SOPs and working instructions
- Proactive approach to identifying and resolving technical compliance challenges
- Strong verbal and written communication skills
- Preferred familiarity with: Electronic Data Capture (EDC), eTMF, Google Suite, AWS, Cloud Storage & Security, Infrastructure as Code/Terraform, GitHub, SQL, and Python
- Experience with Test Automation Tools or Application Lifecycle Management (ALM)
- Expertise in Black Box Testing, Graphical User Interface (GUI) Testing, User Acceptance Testing, Database Testing, System, Functional, and Regression Testing
- Participation in Sponsor Audits and Regulatory Inspections
- Experience in CAPA
- Conducting internal and external audits and regulatory inspections
- Familiarity with Real World Data / Real World Evidence (RWD/RWE)
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Technical Compliance Manager - Boston, United States - OM1, Inc.
Description
OM1 is dedicated to enhancing health outcomes by leveraging the potential of data. Our focus is on healthcare data and technology, aiming to expedite medical research and tailor healthcare services. We boast an interdisciplinary team proficient in medicine, software, Big Data, machine learning, public health, and mathematics. By transforming records from various sources into enriched data, we uncover exclusive insights across multiple disease domains.
This position involves overseeing technical compliance procedures. You will manage the validation program and collaborate closely with engineering teams to ensure systems align with regulatory standards.
The role requires fostering strong cross-functional relationships within the organization. Additionally, you will contribute to Training, Audit, Document Control, Quality (QA) / Compliance Support, Corrective Actions and Preventive Actions (CAPA), Vendor Management, and other duties in line with OM1's entrepreneurial ethos.
What You'll Do at OM1
What Experience You'll Bring
What's Nice to Have
OM1 is an equal opportunity employer, valuing diversity and considering all applicants without bias. Upholding an environment where everyone feels respected, valued, and included is crucial to our success. We are dedicated to fostering a workplace that embraces diversity, equity, and inclusion.
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