Job Opportunities API

Hi Tarsan!  Thanks for your interest in this position.  Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better.   - Your Human Resources Team About the Role The Manager II, Enterprise Applications (R&D & GxP Systems) is a hands-on role responsible for GxP IT system owner activities across GxP applications, ensuring compliant operations in partnership with the business, Quality, and vendor partners. The role includes configuring and testing the systems, maintaining validation activities, managing system upgrades and releases, and contributing to SOPs, training, and process improvements to keep systems aligned with business needs and regulatory requirements. Let’s talk about some of the key responsibilities of the role: Act as a subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault platforms and other validated systems supporting Clinical, Regulatory, Quality and other regulated functions Support the execution of the IT roadmap and system implementations for Clinical, Regulatory and other functional teams performing requirements gathering, risk assessment, impact assessment, solution design, system configurations, testing, and validation activities. Perform requirement gathering, risk assessment, impact assessment of new implementations and existing systems changes Collaborate with business stakeholders, IT, Quality and external vendors to implement new systems and provide day-to-day operations support for assigned GxP systems Partner closely with Quality and external vendor partners on GxP systems operations, change management, CAPAs, periodic reviews, GxP inspection readiness, and support audits/inspections, including presenting system documentation when required Coordinate and support validation testing including user acceptance testing (UAT) of system changes and ensure quality production deployments Review and own IT activities for change control requests and provide all required documentation for GxP systems Assist with data management, migration, integration, and analytics across GxP systems, ensuring business needs are met Manage periodic reviews, upgrades and releases including release assessments. Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness Contribute to the development, review, and maintenance of SOPs, work instructions, and policies related to GxP systems Ensure the assigned GxP systems remain inspection-ready, with complete, accurate, and defensible validation and compliance documentation Factors for Success: Bachelor’s degree in Computer Science, Information Systems, Engineering, Quality, Regulatory, or Business, with 8+ years of relevant IT experience in the life sciences or pharmaceutical industry 6+ years of experience implementing and supporting GxP systems, including clinical, regulatory, quality and other GxP applications Solid understanding of business processes, System Development Lifecycle (SDLC) and validation in a GxP-regulated setting, including strong knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance practices; familiarity with ICH GCP regulations is a strong plus Hands-on experience with Veeva Vault applications (e.g. RIM, CTMS, eTMF ) strongly preferred; certifications in Veeva Vault modules are a plus Experience working with a QMS, GxP LMS systems or other GxP systems is a plus Working knowledge and familiarity with statistical tools (e.g., Minitab, JMP); exposure to JReview for analytics is a plus Familiarity with both waterfall and Agile project management