Our client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Their mission is to transform and make simpler care for people with life-threatening diseases around the globe.
Specific Responsibilities and Skills
• Senior software quality/validation professional, responsible for designing and leading the testing and validation of applications/systems, including leading resources inside or outside the organization.
• Leads the testing /validation efforts of small to large sized projects.
• Conducts, provides and is accountable for the accuracy of work estimates for testing/validation activities. Anticipates changes to the project estimate and escalates accordingly.
• Reports on test results to project team members.
• Accountable for providing the project teams with testing/validation results to make the determination that a system is ready to move into production Manages vendors as necessary.
• Serves as a test lead on projects including defining the scope and testing approach, reviewing requirements and technical documentation for usage, testability and traceability, deploying and managing the testing framework, and managing testing resources.
• Leads test plan & test case development, reviews and approval.
• Provides direction to vendor resources on projects ( as appropriate) including forecasting and tracking expenditures.
• Developing and documenting User, Functional and Design requirements; Installation.
• Operational and Performance Qualification protocols and reports; Standard Operating.
• Procedures; requirements traceability; Infrastructure Qualification and change control.
• Leading and managing people who perform qualification/validation activities in accordance with requirements, master plans, procedures and protocols.
• Providing training and support to IT staff on change control, issues and audit preparation.
• Collaborate with regulatory specialists in Legal, Quality and Compliance to develop IT methodology to implement compliance in an efficient manner.
• Providing support for systems used in drug development, manufacturing, quality control and quality assurance.
Essential Duties and Job Functions
• Can assist with design considerations for more complex projects that may involve
• multiple technical teams.
• Participates in the identification of risks and the development of mitigation strategies for projects.
• Supports project teams to provide assurance that requirements, design, and other project deliverables meet standards as appropriate.
• Drives test execution and status reporting.
• Manages and monitors defect reports and works with developers and other project team members to verify resolution.
• Serves as coach and mentor to more junior testing staff.
Knowledge, Experience and Skills
• Has a strong working knowledge of the testing process, designing test scenarios and test scripts, including of understanding of various software quality practices with the ability to learn and apply new and emerging concepts very quickly. Has to have GxP, 21 CFR Part 11, FDA regulatory and quality experience
• Demonstrates an understanding of application development methods, the project management process, as well as the fundamentals of requirement specification design, and development/configuration.
• Has experience leading testing efforts on projects, estimating schedules, resources and dependencies.
• Has developed a broad understanding of the environment at company, to apply an understanding of the interoperability of systems and technologies to the testing/validation effort.
• Has experience applying automated testing tools.
• Serves as a resource to project team on regulations related to testing and documenting automated systems.
• Typical candidates will possess 5+ years of relevant experience and BA/BS degree, or equivalent.
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