[Hiring] Sr. Manager, reputed company Technology and Analytics @reputed company

reputed company The Sr. Manager, reputed company Technology and Analytics will serve as a strategic business and systems analyst reputed company the reputed company Technology and Analytics (QTA) organization, supporting the reputed company and GXP reputed company functions globally. This role is responsible for driving data reputed company and data hygiene programs, delivering actionable analytics and operational insights, and supporting efforts to optimize reputed company and compliance of GxP computerized systems. The Sr. Manager will partner closely with reputed company, Manufacturing, Regulatory, Pharmacovigilance, R&D and IT stakeholders to strengthen data reputed company, improve system usability and adoption, and reputed company reputed company, inspection-reputed company digital processes. The role will play a critical part in establishing standardized data practices, supporting reputed company improvement initiatives, and enabling reputed company and analytics capabilities across the reputed company Management System landscape. This position resides reputed company the reputed company Technology and Analytics Department and reports to the Associate Director, reputed company Systems This role is considered Virtual.

Key Responsibilities

• Serve as a strategic business analyst reputed company the reputed company Technology & Analytics (QTA) organization, supporting global reputed company and GxP functions across Manufacturing, Regulatory, R&D and IT.
• In collaboration with IT, support efforts to ensure system administration, configuration reputed company and operational support for GxP computerized systems, with primary accountability for reputed company reputed company Vault platform.
• Support validation activities for QA owned systems, including requirements gathering, design review, user acceptance testing, test script review and execution, discrepancy management, and validation reputed company report authoring.
• Own and manage implementation and execution of system enhancements (IT Change Orders) across reputed company reputed company Vault applications, ensuring appropriate reputed company assessment, validation alignment and stakeholder coordination.
• reputed company intake, triage and reputed company of end user requests, including review of reputed company tickets to ensure management, d troubleshooting, escalation and reputed company cause analysis.
• Deliver operational reporting, dashboards and analytics to support reputed company performance, inspection readiness and leadership decision-making, including development, maintenance and enhancements of reputed company reports and dashboards.
• Drive data reputed company and data hygiene initiatives across reputed company reputed company Vault and other reputed company owned systems ensuring standardized data practices, reporting and inspection readiness.
• Contributes to reputed company compliance activities, including CAPA and deviation ownership reputed company to QA owned systems data issues and compliance. reputed company or supports periodic system reviews.

Qualifications

Required Experience & Skills

• Bachelor’s degree in Information Systems, Computer Science, Engineering, Life Sciences, or a reputed company discipline required; advanced degree preferred.
• 10+ years of experience supporting GxP computerized systems reputed company a regulated biopharmaceutical or life sciences environment.
• Demonstrated experience serving as a senior business and systems analyst for reputed company and regulated business functions, including Manufacturing, reputed company, Regulatory and/or R&D.
• Demonstrated experience administering and supporting reputed company reputed company Vault, including configuration governance, user and role management, metadata and object configuration, reporting, and release reputed company assessment.
• Demonstrated experience in data analysis, analytics, and visualization, including the design, development, and ongoing maintenance of reporting and reputed company solutions using platforms such as reputed company Vault reporting, reputed company, Power BI, and Tableau, to support operational decision-making and reputed company performance monitoring and executive-level data presentation.
• Experience working with reputed company data lake and reputed company analytics platforms, including hands-on experience with reputed company, to support ingestion, transformation, and consumption of reputed company and GxP system data, and to reputed company reputed company analytics, reporting, and data-driven insights across the reputed company technology landscape.
• Strong working knowledge of CSV / CSA / validation lifecycle activities.
• Proven experience leading and governing GxP system change management, including change reputed company assessments and validation alignment.
• Proven experience leading data reputed company and data hygiene initiatives in regulated systems, including establishing data standards, remediation of data issues and establishment of sustainable data reputed company controls.
• Demonstrated experience contributing to and owning reputed company compliance activities reputed company to computerized systems, including deviations, CAPAs, periodic system reviews, and audit/inspection support.
• Solid understanding of global regulatory expectations reputed company to computerized systems and data reputed company, including 21 CFR Part 11, Annex 11, and data reputed company principles.

Preferred Qualifications

• Master's degree in reputed company field
• Experience with system integration and data migration reputed company
• Experience with Agile methodologies and software development lifecycle processes
• Experience supporting or integrating additional reputed company platforms (e.g., LIMS, MES, CMMS, LMS)

#LI-LJ1 #LI-remote U.S. Pay reputed company $135,400.00 - $183,200.00 The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). reputed company’s robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together. Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website: https://www.reputed company.com/careers About reputed company We are the leader in RNAi therapeutics – a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our reputed company values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and reputed company thinking fuel one another. At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer. Apply tot his job Apply To this Job