You'll play a key role in ensuring that Quality Management Systems and Regulatory Information Management applications are compliant, stable, and effectively support business needs across the organization.

- In this role, you will act as the global application expert for platforms such as QUMAS (QMS), Veeva RIM, and DocuBridge, working closely with QA/RA, IT, and business stakeholders across sites. You will provide hands-on support, manage system configurations, and ensure smooth day-to-day operations while contributing to the organizations digitalization and quality transformation initiatives.

A strong understanding of GxP environments, regulatory compliance, and Computerized System Validation (CSV) is essential, along with deep expertise in QMS applications.

- You will be responsible for maintaining system stability, performance, and compliance by managing incidents, service requests, and system changes in collaboration with internal teams and external vendors.

- The role also involves preparing and maintaining accurate documentation, including SOPs, functional specifications, and validation records, while ensuring systems remain in a validated state through proper lifecycle and change management.

- In addition, you will design and implement system enhancements to improve workflows, user experience, and compliance outcomes, working closely with business stakeholders to drive continuous improvement and execute the global application roadmap.

- You will also support audits and inspections, manage CAPAs with a focus on root cause analysis, and participate in governance forums such as Change Advisory Boards to ensure structured and compliant system changes.

- Strong stakeholder engagement is critical, as you will collaborate with global QA, RA, IT, validation teams, and external vendors, ensuring clear communication, SLA adherence, and timely delivery. You will also oversee data integrity, system performance, and usage trends, proactively managing system capacity and license utilization to ensure operational readiness.

Qualifications & Experience :

- Bachelor/ Masters degree in computer science, Information Systems, or related field.

- A minimum of 5 years as an IS/IT Application specialist within QMS and Regulatory Information Management Applications within Life science/CDMO

- Knowledge in QA and RA processes within the pharmaceutical/CDMO industry.

- Strong experience in validation of QMS and Regulatory Information Management

- Applications (computer system validation, CSV)

- Experience working in GxP-regulated environments.

- Proven ability to work in structured, process-driven environments, handling change management and continuous improvement.

- Excellent stakeholder management skills, collaborating with QA and RA

- departments, validation teams, and IT professionals across global sites.

- Strong problem-solving and analytical skills, with a proactive mindset towards process optimization and system improvements.