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Job ID 2019-1977
# of Openings 1
Category Quality – Dept
The QA Computer Systems Validation (CSV) Manager will provide computer systems validation oversight and execution across the IT System Development Lifecycle for all applications that support Radius Health GxP (Good Clinical / Manufacturing / Laboratory / Pharmacovigilance / Distribution Practices) regulated activities, and ensure compliance with Code of Federal Regulations (CFR) 21, Part 11 regarding electronic records and electronic signatures.
- Guides system stakeholders through the SDLC process and drafts and/or reviews and edits project related validation deliverables (Risk Assessments and Validation Determinations, Validation Master Plans, User/Functional/Technical Requirements, IQ/OQ and PQ/UAT Test Protocols and Scripts, Traceability Matrices, Validation Summary Reports)
- Drafts policies, standard operating procedures, and work instructions supporting the quality management system and computerized/IT infrastructure system.
- Provides regulatory guidance and best industry practices in support of quality management system and computer system validation
- Review and approve IT Change Controls
- Lead or contribute to site IT Audits to ensure compliance to regulatory guidance and to policies and procedures
- Lead or contribute to Supplier Audits and IT Services Quality Agreements to ensure compliant supplier management
- Contribute to ongoing quality initiatives, metrics and compliance enforcement
- Assists, as necessary, with project management activities, including but not limited to the generation of project schedules, meeting minutes, and technical documents
- Serves as test coordinator/reviewer and where necessary, executes Test Scripts according to good testing and documentation practices
- Supports regulatory authority inspections, including retrieval, logging, and tracking document requests
- Maintains compliance with applicable regulations (21 CFR 58, 210, 211, 820, and Part 11) and assists with SOX testing/compliance, when required
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.
- 5 to 10 years’ experience in a regulated (pharmaceutical industry) environment
- Bachelor’s degree in the life sciences or Information Technology field required
- Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance
- Working knowledge of Project Management and Software Development Life Cycles
- Familiarity with computer infrastructure, servers, workstations, operating systems and data base management systems
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