
Senior IT Compliance Specialist
2 days ago
Mazo Solutions is seeking a highly experienced Senior IT Compliance Specialist to join our team. In this role, you will be responsible for ensuring the compliance of our IT infrastructure with regulatory requirements such as 21 CFR Part 11, EU Annex 11, and GAMP5.
About the RoleThis is a critical position that requires strong technical expertise in IT compliance, particularly in the life sciences, pharmaceutical, and medical device industries. You will work closely with system owners, technical representatives, and business owners to ensure compliance and quality.
Key Responsibilities- Execute Computer System Validation (CSV) activities for laboratory and manufacturing computerized systems.
- Design and develop qualification plans, including deliverables, user requirements, and functional specifications for GxP-relevant infrastructure components.
- Prepare test cases and scripts to verify qualification after changes to infrastructure components.
- Create walkthrough narratives and process flow diagrams to identify key GMP controls and processing risks.
- Execute qualification protocols, document deviations, and recommend resolutions.
- Assess and qualify cloud infrastructure services supporting GxP applications.
- Coordinate and execute infrastructure component/platform test execution efforts.
- Conduct Quality Control reviews of qualification activities and deliverables.
- 10+ years of experience in qualification and validation writing and execution.
- Strong expertise in IT compliance for life sciences/pharmaceutical/medical device industries.
- 4+ years of experience in Change Management processes related to IT infrastructure.
- In-depth experience qualifying cloud services (SaaS, PaaS, IaaS) and supporting GxP applications.
- Hands-on experience with SOC 2 reports, CUEC, and IT controls management.
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, and paid time off.
The estimated salary for this position is $150,000 per year, based on industry standards and location.
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