IT Quality
Location: Remote – India (25% Travel Required)
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Manager, IT Quality in our Information Technology function within the Spine division, you’ll lead the IT Quality and Computer System Validation program for GxP-regulated systems. You will ensure that all computerized systems used in Quality, Regulatory, and other critical business processes are validated, compliant, and maintained to the highest standards, while partnering closely with Quality, Regulatory, and business stakeholders across the
What You’ll Do:
IT Quality & Validation Leadership
- Own and lead the end-to-end Computer System Validation (CSV) and IT Quality lifecycle for GxP applications, including validation planning, risk assessment, testing strategy, execution oversight, and approval readiness
- Ensure systems remain in a validated state through effective change management, periodic reviews, and lifecycle controls
- Partner with Quality Assurance, Regulatory, IT, and business teams to align compliance activities with regulatory expectations and business needs
- Drive adoption of risk-based, efficient validation approaches, templates, and best practices across the organization
GxP Application Compliance & Support
- Oversee compliance and operational support for key GxP applications, ensuring maintenance, enhancements, incidents, and changes are handled compliantly
- Review and approve system changes for validation impact and documentation requirements
- Manage and provide governance over outsourced/managed service partners responsible for validation delivery, testing, and support activities
- Support system implementation, enhancements, retirement, backup verification, access reviews, and disaster recovery activities
Governance, Documentation & Continuous Improvement
- Maintain validation documentation, dashboards, trackers, and reports to support inspection readiness and compliance health monitoring
- Facilitate governance meetings and status updates for IT Quality and validation activities
- Identify and drive continuous improvement opportunities in validation processes, documentation quality, and vendor performance
- Develop and maintain SOPs, work instructions, training materials, and quality procedures related to IT Quality and validation
- Contribute to strategic IT and regulatory transformation initiatives impacting GxP systems
What You Bring:
- Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, Quality, or related field
- Minimum 8+ years of experience in IT Quality, Computer System Validation (CSV), or regulated IT support within medical device, pharmaceutical, or life sciences industries
- Strong working knowledge of GxP regulations, 21 CFR Part 11, Annex 11, GAMP, and risk-based validation approaches
- Demonstrated experience leading validation activities across the full system lifecycle (implementation, change management, and operations)
- Experience managing or working with managed service / outsourced validation partners
- Excellent written and verbal communication skills with the ability to produce inspection-ready documentation
- Strong analytical, problem-solving, and stakeholder management skills
- Ability to work independently in a remote environment while managing multiple priorities across global time zones
Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing global IT team where you’ll play a strategic leadership role in ensuring the quality, compliance, and reliability of systems that support life-changing spinal technologies.
Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position will align with senior IT leadership roles in the Indian market, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, technical expertise, and local market conditions.
Benefits include:
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic global company
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