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Sr. Manager – Computerized Systems Validation and IT Compliance
| Company | Bristol Myers Squibb |
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| Location | Bothell, WA, USA |
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| Salary | $154500 – $185960 |
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| Type | Full-Time |
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| Degrees | Master’s |
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| Experience Level | Senior |
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Requirements
- Master’s degree or foreign equivalent degree in Chemical Engineering or a related field
- Five (5) years of post-baccalaureate experience
- Experience with Six Sigma, quality system, computerized system, CSV, technical writing, and quality management
- Six Sigma Green Belt certificate is required
Responsibilities
- Lead development of the computerized systems validation strategy, including stage gate deliverables
- Plan and manage assigned CSV (Computerized Systems Validation) projects
- Manage author, review and/or approve processes for applicable CSV lifecycle documentation
- Ensure the validation of computerized systems used across GXP (Good x Practice) operations is conducted in compliance with applicable regulatory requirements and internal procedures
- Partner with Business Owners, IT, and QA to ensure a compliant management of the computerized systems lifecycle
- Act as subject matter expert for CSV and IT Quality during regulatory inspections
- Conduct impact assessments for changes impacting validated computerized systems
- Maintain the inventory of all computerized systems and requalification / revalidation schedules
- Oversee internal validation employees and external contractors, including training, assignment of projects and ensuring the timely completion of their deliverables
- Track CSV deliverables and provide periodic progress reports to upper management and stakeholders
- Manage department metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements
- Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
- Participate in governance boards, acting as the IT representative for regulatory and procedural compliance using experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) related activities
- Support regulatory inspections as a SME (subject matter expert) and manage supporting contract resources
- Perform and lead investigations and root cause analyses for Quality Event deviations related to IT systems
- Author and contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, and SOPs
Preferred Qualifications
No preferred qualifications provided.
