Job
Description
Roles & Responsibilities: Collaborates with internal teams, including IS functions (Infrastructure, ITIL process owners), external service providers, Corporate Quality, and Medinfo business units. Leads and develops test plans, test cases, test scripts and test reports on multiple projects and ultimately validates that expectations of our users are met during the testing process Responsible for defect tracking, investigation, and resolution throughout testing and validation phases. Prepare, review, and approve test cases to validate system functionality and performance against business requirements. Review and execute Test Runs in alignment with pre-approved testing protocols and documentation best practices. Create, review, and maintain the Requirements Traceability Matrix (RTM) to ensure full test coverage and validation compliance. Lead the creation and review of Validation Summary Reports (VSRs), capturing outcomes, deviations, and traceability to requirements. Draft and manage OQ Pre/Post-Approval Protocols, including alignment with qualification strategy and risk assessments. Collaborate closely with the Amgen Quality Assurance team to ensure validation artifacts meet regulatory and audit-readiness criteria. Drive Change Request (CR) and Change Control processes, from initiation through approval, ensuring accurate system impact assessment and documentation. Initiate and manage ISM Change Requests for release planning and versioning coordination. Serve as the primary liaison for internal and external stakeholders, ensuring cross-functional alignment during validation lifecycle activities. Ensure timely documentation reviews and approvals in accordance with Amgens standard operating procedures and regulatory requirements. Maintain and enforce validation lifecycle documentation, including Test Plans, Protocols (IQ/OQ/PQ), Design Specifications, and Summary Reports. Drives advancements of automated testing, based on ongoing analysis of manual testing efforts versus efforts to keep test automation current Support system go-lives, data migrations, and infrastructure changes with appropriate validation oversight. Contribute to the continuous improvement of validation templates, SOPs, and risk-based testing strategies. Provide mentorship on compliance issues related to computerized systems, validation best practices and documentation quality and ensure continuous improvement of validation processes. Support regulatory audits and inspections, providing documentation and expert insights as needed. Demonstrate leadership in the end-to-end validation activities for complex IT GxP projects and to operate in alignment with CSV regulations; ITIL Change and Problem Management. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 3 to 4 years of Computer Science, IT or related field experience OR Bachelors degree and 5 to 6 years of Computer Science, IT or related field experience OR Diploma and 9 to 10 years of Computer Science, IT or related field experience Preferred Qualifications: Demonstrated leadership in GxP validation for complex IT systems and enterprise platforms. Proven experience in validating GxP-critical systems per 21 CFR Part 11, Annex 11, and data integrity standards Proven experience in creating and managing validation artifacts including Validation Plans (VMP) Test Plans, IQ/OQ/PQ Protocols, RTMs, and VSRs. Strong working knowledge of change control systems, including CR and CCMS processes. Proficiency in Quality Management Systems (QMS), including electronic documentation and workflow tools. Experience using ServiceNow, HP ALM, or similar platforms for defect tracking and testing. Effective collaboration with Quality, Regulatory, and IT functions in a regulated industry environment. Deep understanding of SDLC and CSA principles. Experience supporting regulatory inspections and audits. Knowledge of Agile and SAFe methodologies in a validation context. Pharmaceutical industry experience is a strong plus. Must-Have Skills: Proficient in using enterprise tools such as ServiceNow, HP ALM for managing defect tracking, test execution, and validation workflows, ensuring traceability, accountability, and audit-ready documentation throughout the project lifecycle Ability to manage complex change processes, including initiating, reviewing, and approving change requests and attending Change Approval Board meetings. Skilled in partnering with internal IT, Quality Assurance, external vendors, and business units to align validation deliverables with evolving regulatory expectations and business priorities. Proficient in leading test plans, test scripts, reports, requirements traceability, and execution of IQ/OQ/PQ protocols within regulated GxP and CSV-compliant computer systems, ensuring adherence to validation, audit, and documentation standards Good-to-Have Skills: Experience with stakeholder management, ensuring seamless coordination across teams and driving the successful delivery of technical projects Experience supporting regulatory audits and inspections, with the ability to provide validation documentation and subject matter expertise Experience enhancing validation SOPs, templates, and documentation tools for continuous improvement Ability to lead and facilitate cross-functional validation activities with geographically dispersed teams Exposure to testing integrations with platforms like Salesforce, AWS, MuleSoft, or other enterprise systems Experience supporting regulatory inspections and audits, with the ability to present validation documentation and processes confidently. Familiarity with Agile and SAFe frameworks, with the ability to integrate validation practices into iterative development cycles. Professional Certifications Certified Computer System Validation Professional (CSV) SAFe for Teams or SAFe Scrum Master (preferred) ISTQB or equivalent software testing certification Soft Skills: Excellent leadership, coaching, and mentoring capabilities. Strong analytical, problem-solving, and critical-thinking skills. Outstanding communication and stakeholder management abilities. Proactive and self-motivated with a keen eye for detail. Ability to manage multiple projects and competing priorities in a fast-paced environment. A collaborative spirit with a passion for quality and compliance excellence. Experience in working with Quality Assurance (QA) and Regulatory/Compliance teams for audits and inspections
