Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance team. Job duties will include: Reviewing and providing input to validation and test strategies Verifying documentation is in compliance with internal procedures and external regulations Participating in review and approval of requirements, test scripts, reports, and other SDLC documentation with a focus on quality and testability In addition, the resource may be pulled to support other programs as needed: Participating in process changes in the organization Participating in audits Participating in change management of additional systems Education/Training/Work Experience: The position requires a Bachelor’s Degree in Engineering or Sciences with a minimum of 5-8 years of experience working in the life sciences industry with a focus on Quality Assurance. Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud-based (SaaS) COTS) used in the life sciences industry. Candidates must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model. In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process. Extensive experience developing and using risk-based approaches for computer systems validation. Experience in managing multiple projects and a determination to get the job done correctly and on time. Specialized Knowledge and Skills: Knowledge in SAP is a plus. In addition, Microsoft Office experience (Word, Excel, PowerPoint) is required. Experience with Microsoft SharePoint is also recommended. Good organizational skills and strong interpersonal skills, as well as the ability to work with other departments, are essential. Additional Information All your information will be kept confidential according to EEO guidelines. J-18808-Ljbffr