Testing Lead

• Test Strategy & Execution

• Design and execute end-to-end testing strategies for RIM modules including: *

• Registration Management
• Submissions Management
• Product Tracking
• IDMP
• Develop comprehensive testing plans and validation approaches
• Ensure testing coverage aligns with business and regulatory requirements

Validation & Compliance

• Lead validation activities to ensure compliance with: *

• FDA 21 CFR Part 11
• GxP standards
• EMA data standards
• Support regulatory and quality compliance initiatives
• Ensure systems meet validation and audit requirements

Documentation:

• Create and review: *

• Validation Master Plans (VMPs)
• Test Protocols
• Test Scripts
• Requirements Traceability Matrices
• Validation documentation packages

Testing Coordination *

• Functional Testing
• Integration Testing
• User Acceptance Testing (UAT)
• Data Migration Testing

Work with global teams to execute testing activities efficiently.

• Ensure testing milestones are achieved on schedule
• Defect Management
• Manage defect lifecycle processes
• Perform root cause analysis
• Track and prioritize issues
• Report testing status and quality metrics to leadership teams
• Stakeholder Collaboration

Partner with: *

• Regulatory Operations
• Business Analysts
• Vendors
• Quality Teams
• Define acceptance criteria for complex regulatory workflows
• Support business users throughout testing and validation activities

Technical Skills:

• Regulatory Systems
• Veeva Vault RIM
• Ennov
• Regulatory Information Management (RIM) platforms
• Regulatory Compliance
• eCTD submissions
• IDMP standards
• FDA 21 CFR Part 11
• GxP compliance
• CSV methodologies

Testing & Quality Assurance:

• Functional Testing
• Integration Testing
• UAT
• Data Migration Testing
• Defect Tracking
• Validation Documentation Tools
• Azure DevOps
• Test Management Platforms
• Validation Management Tools

We are seeking an experienced Testing Lead to oversee quality assurance, validation, and testing activities for Regulatory Information Management (RIM) platforms within a highly regulated life sciences environment.

This role will lead end-to-end testing strategies, validation activities, compliance initiatives, and cross-functional testing efforts to ensure successful implementation and deployment of regulatory systems.

The ideal candidate has strong experience with RIM platforms, regulatory affairs processes, computer system validation (CSV), and global regulatory compliance requirements.

Top 3 Required Skills

1. Regulatory Affairs Expertise, with a deep understanding of: *

• Regulatory affairs processes
• eCTD submissions
• IDMP standards
• Experience supporting global regulatory operations and compliance initiatives

1. Computer System Validation (CSV)

• Hands-on experience with: *

• Computer System Validation (CSV)
• FDA 21 CFR Part 11 compliance
• GxP compliance requirements
• Life sciences regulatory guidelines

1. Testing & Automation

• Strong experience developing: *

• Manual test scripts
• Automated test scripts

• Experience using testing and project management tools such as: *

• Azure DevOps, * Bachelor’s Degree in: *

• Life Sciences
• Computer Science
• Information Technology
• Related field

Experience

• 7+ years of software quality assurance experience

• 3+ years focused on RIM implementations, including platforms such as: *

• Veeva Vault RIM
• Ennov
• Experience within pharmaceutical, biotechnology, medical device, or regulated life sciences environments, We are looking for someone who:
• Has extensive experience leading testing efforts within life sciences organizations
• Understands regulatory submission and product registration processes
• Has hands-on experience with RIM implementations
• Excels in validation and compliance activities
• Can work effectively with global teams and stakeholders
• Is highly organized, detail-oriented, and quality-focused

SGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries. We’re a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters.

Are you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact?

Explore opportunities Grow your career Be part of something global Your future starts here., Who We Are\r\nSGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries. We’re a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters.\r\n\r\nAre you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact?\r\n\r\nExplore opportunities\r\nGrow your career\r\nBe part of something global\r\nYour future starts here.