IT质量负责人
IT Quality Lead
IT Quality Lead，
地点：印度
公司：VB Spine
寻找一份工作，让你的付出真正有意义？在 VB Spine，你将加入一个以使命为导向的团队，在关键的脊柱手术中支持外科医生。我们正在寻找充满动力的人才，他们能够快速学习、在压力下适应并成长于一个动态且快节奏的环境中。
作为 IT Quality Lead，你将成为 IT 和业务领导值得信赖的合作伙伴，推动技术项目中的质量、合规和验证卓越。
你将领导质量保证和计算机系统验证活动，建立并维护质量标准，确保技术解决方案可靠、合规且高效地交付。跨全球团队协作，你将监督验证计划，识别并缓解风险，推动持续改进，并在整个软件开发生命周期中加强质量实践。
此职位适合一位积极主动的专业人士，擅长在动态环境中工作，享受构建可扩展流程，并能在受监管的医疗设备（MedTech）组织中有效平衡速度、结构和业务需求。
你将负责：
- 在整个系统生命周期内领导和支持计算机系统验证（CSV）活动，包括验证计划、风险评估、测试策略、执行监督和验证交付物。
- 推动 GxP 监管应用、数据迁移项目和基础设施验证活动的验证工作，以确保合规性和运营准备就绪。
- 通过有效的变更管理、定期审查、生命周期管理和持续合规监控，确保计算机化系统保持验证状态。
- 与 IT、质量保证、法规事务、业务利益相关者和供应商合作，提供合规、高效且与业务对齐的技术解决方案。
- 应用基于风险的验证方法和行业最佳实践，优化验证活动，同时保持监管合规。
- 支持关键 GxP 系统的治理和合规，包括系统实施、增强、升级、退役、访问审查、备份验证和灾难恢复测试。
- 审查并批准系统变更，确保满足适当的验证影响评估、测试要求和文档标准。
- 监督并与外部服务提供商和实施合作伙伴协作，以确保…
查看英文原文
IT Quality Lead,
Location:India
Company:VB Spine
Looking for a career where your work truly matters? At VB Spine,you’llbe part of a mission-focused team that supports surgeons during life-changing spinal procedures.We’relooking 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.
WhatYou’llDo:
- 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’llget the training, mentorship, and support you need to builda strong foundationin the medical sales field.You’llwork alongside a high-performing team, gain valuableoperating roomexperience, 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.
Originally posted on Himalayas