Rochester Regional Health
IT Technical Regulatory Compliance Principal
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Job Description
- Req#: REQ_229093
Employer Industry: Life Sciences and Healthcare
Why consider this job opportunity:
- Salary up to $150,000.00
- Opportunity for career advancement and growth within a leading life sciences organization
- Flexible remote work option available
- Engage in impactful work ensuring compliance with regulatory standards in laboratory services and clinical trials
- Collaborative and supportive work environment with cross-functional team engagement
- Comprehensive benefits package including health, dental, and retirement plans
What to Expect (Job Responsibilities):
- Lead IT compliance initiatives ensuring adherence to global regulatory authorities and applicable standards
- Manage and execute validation of cloud-based and hosted applications, including risk assessments and documentation
- Oversee the IT change management process and new system implementation
- Prepare and lead IT-related activities for regulatory inspections and audits, managing quality events and CAPAs
- Author and maintain IT compliance policies and documents to ensure consistent practices across teams
What is Required (Qualifications):
- Bachelor’s degree in computer science
- 10 years of experience in life sciences computer systems validation, including biotech, pharma, or laboratory services
- Five years of employment in a lab services environment
- Five years of experience in a biotech, pharma, or medical device environment
- Strong documentation and technical writing skills, proficient in Microsoft Office tools and SharePoint
How to Stand Out (Preferred Qualifications):
- Detailed knowledge of IT infrastructure and computerized system validation concepts
- Experience with cloud service providers (AWS, Azure) and enterprise applications (e.g., Veeva, Salesforce)
- Familiarity with modern SDLC frameworks (Agile, DevOps) and change management systems
- Strong communication and leadership skills, with the ability to present to executives
- Demonstrated competence in migrating CSV to Computer Software Assurance (CSA) processes
#LifeSciences #HealthcareCompliance #RemoteWork #CareerAdvancement #ITValidation
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