Sr Spec, IT QA RA Global Apps

We are seeking a Senior Specialist, IT QA RA Global Apps to serve as a System Owner and Functional Lead, responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle.

This role requires hands-on experience with quality solutions such as TrackWise, LabVantage LIMS, Veeva RIM Vault, or other Quality & Regulatory applications.

Position Overview

As the Sr Specialist, IT QA RA Global Apps, you will:

• Own and manage Quality & Regulatory applications, ensuring they are designed, operated, and maintained per business requirements.
• Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions.
• Lead system validation, testing execution, and change management in a regulated environment.
• Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams.
• Act as the primary liaison between IT, business process owners, and external vendors.

Key Responsibilities

1. System Ownership & Governance

• Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements.
• Implement solutions that align with business needs and regulatory requirements.
• Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records.
• Ensure systems remain in a validated state throughout their lifecycle.

2. Functional Business Analysis & Solution Design

• Gather, analyze, and document business requirements, workflows, and process improvements.
• Translate business needs into functional and technical specifications.
• Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.
• Ensure solutions are scalable, compliant, and aligned with Vantive's digital transformation strategy.

3. Validation, Testing & Compliance

• Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards.
• Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes.
• Manage risk assessments, audits, and regulatory inspections related to system validation and compliance.

4. System Maintenance, Enhancements & Issue Resolution

• Oversee system upgrades, patches, and maintenance, recommending enhancements as needed.
• Manage issue triage, root cause analysis, and resolution for system defects.
• Work closely with business process owners to ensure applications align with operational needs.
• Coordinate with vendors and internal teams for system support and enhancements.

5. Stakeholder Collaboration & Project Support

• Act as a key liaison between IT, Quality, Regulatory, and business stakeholders.
• Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives.
• Provide end-user training and support, ensuring smooth adoption of system enhancements.
• Assist with project management tasks, ensuring timely delivery of IT solutions.

6. Technical Skills & Experience

The ideal candidate should have a strong technical foundation with hands-on experience in enterprise application support, configuration, and deployment. Key technical competencies include:

• Programming & Scripting: Basic understanding of Java, .NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries.
• Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment.
• Application Deployment & Support: Familiarity with CI/CD pipelines, system integrations, web services (SOAP/REST APIs), and troubleshooting production issues.
• Validation & Compliance: Experience working in a regulated healthcare, pharma, or life sciences environment with understanding of CSV (Computer System Validation) and GxP requirements.

The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications.

Qualifications & Experience

Must-Have Qualifications

• 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry.
• Hands-on experience with Veeva, TrackWise, LabVantage LIMS, or other Quality/Regulatory applications.
• Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance.
• Ability to develop and execute test scripts, validation plans, and system documentation.
• Technical knowledge of SQL, system integrations, and application configuration.
• Bachelor's degree in Computer Science, Information Systems, or a related field.

Preferred Qualifications

• Experience with Salesforce, AWS, Azure, or cloud-based environments.
• Basic project management experience (Agile, Waterfall, or hybrid methodologies).
• Strong problem-solving and analytical skills to address complex system issues.
• Excellent communication and stakeholder management skills.