Website:
vbspineco.com
Job details:
IT Quality Lead,
Location: India
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 looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment.
As an IT Quality Lead, you will be a trusted partner to IT and business leaders, driving quality, compliance, and validation excellence across technology initiatives.
You will lead quality assurance and computer system validation activities, establish and maintain quality standards, and ensure technology solutions are delivered reliably, compliantly, and efficiently. Working across global teams, you will oversee validation programs, identify and mitigate risks, drive continuous improvement, and strengthen quality practices throughout the software development lifecycle.
This role is well suited to a proactive professional who excels in dynamic environments, enjoys building scalable processes, and can effectively balance speed, structure, and business needs in a regulated MedTech organization.
What You’ll Do
- Lead and support Computer System Validation (CSV) activities across the full system lifecycle, including validation planning, risk assessments, testing strategies, execution oversight, and validation deliverables.
- Drive validation efforts for GxP-regulated applications, data migration projects, and infrastructure qualification activities to ensure compliance and operational readiness.
- Ensure computerized systems remain in a validated state through effective change management, periodic reviews, lifecycle management, and ongoing compliance monitoring.
- Partner with IT, Quality Assurance, Regulatory Affairs, business stakeholders, and vendors to deliver compliant, efficient, and business-aligned technology solutions.
- Apply risk-based validation methodologies and industry best practices to optimize validation activities while maintaining regulatory compliance.
- Support governance and compliance for critical GxP systems, including system implementations, enhancements, upgrades, retirements, access reviews, backup verification, and disaster recovery testing.
- Review and approve system changes, ensuring appropriate validation impact assessments, testing requirements, and documentation standards are met.
- Oversee and collaborate with external service providers and implementation partners to ensure high-quality delivery of validation, testing, and support services.
- Develop, maintain, and enhance validation documentation, procedures, SOPs, training materials, dashboards, and compliance metrics to support inspection readiness.
- Identify and drive continuous improvement initiatives that strengthen IT Quality processes, increase operational efficiency, improve vendor performance, and support regulatory and business transformation programs.
What You Bring
- Bachelor’s degree in Information Technology, Computer Science, Business Administration, or a related field.
- 4+ years of experience in IT Quality, Computer System Validation (CSV), IT Compliance, or regulated IT environments within Life Sciences.
- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, GAMP, and risk-based validation practices.
- Experience supporting validation activities across the system lifecycle, including implementation, testing, change management, and operations.
- Familiarity with validation documentation such as validation plans, risk assessments, traceability matrices, and IQ/OQ/PQ protocols.
- Experience with data migration validation, infrastructure qualification, or technology transformation projects is preferred.
- Strong stakeholder management, communication, and documentation skills, with the ability to work effectively across global teams.
- Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced, regulated environment.
- Proactive, solution-focused mindset with the ability to work independently and drive continuous improvement.
Why VB Spine?
We believe in growing talent from within. At VB Spine, you’ll get the training, mentorship, and support you need to build a strong foundation in the medical sales field. You’ll work alongside a high-performing team, gain valuable operating room experience, and take your first step toward a rewarding and meaningful career.
Compensation
Compensation for this role is competitive and based on experience, qualifications, skills, and local market conditions. Final compensation will be determined on a case-by-case basis.
Click on Apply to know more.
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