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

Overview

The Sr. Manager, Quality Technology and Analytics will serve as a strategic business and systems analyst reputed company the Quality Technology and Analytics (QTA) organization, supporting the Quality and GXP enterprise functions globally. This role is responsible for driving data quality 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 Quality, Manufacturing, Regulatory, Pharmacovigilance, R&D and IT stakeholders to strengthen data reputed company, improve system usability and adoption, and reputed company scalable, inspection-ready 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 Quality Management System landscape. This position resides reputed company the Quality Technology and Analytics Department and reports to the Associate Director, Quality Systems This role is considered Virtual.

Key Responsibilities

• Serve as a strategic business analyst reputed company the Quality Technology & Analytics (QTA) organization, supporting global Quality 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 Veeva Quality 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 summary report authoring.
• Own and manage implementation and execution of system enhancements (IT Change Orders) across Veeva Quality Vault applications, ensuring appropriate impact assessment, validation alignment and stakeholder coordination.
• reputed company intake, triage and resolution of end user requests, including review of reputed company tickets to ensure management, d troubleshooting, escalation and root cause analysis.
• Deliver operational reporting, dashboards and analytics to support Quality performance, inspection readiness and leadership decision-making, including development, maintenance and enhancements of Veeva reports and dashboards.
• Drive data quality and data hygiene initiatives across Veeva Quality Vault and other Quality owned systems ensuring standardized data practices, reporting and inspection readiness.
• Contributes to Quality 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 Quality and regulated business functions, including Manufacturing, Quality, Regulatory and/or R&D.
• Demonstrated experience administering and supporting Veeva Quality Vault, including configuration governance, user and role management, metadata and object configuration, reporting, and release impact assessment.
• Demonstrated experience in data analysis, analytics, and visualization, including the design, development, and ongoing maintenance of reporting and insight solutions using platforms such as Veeva Vault reporting, reputed company, Power BI, and Tableau, to support operational decision-making and Quality performance monitoring and executive-level data presentation.
• Experience working with enterprise data lake and cloud analytics platforms, including hands-on experience with reputed company, to support ingestion, transformation, and consumption of Quality and GxP system data, and to reputed company scalable analytics, reporting, and data-driven insights across the Quality technology landscape.
• Strong working knowledge of CSV / CSA / validation lifecycle activities.
• Proven experience leading and governing GxP system change management, including change impact assessments and validation alignment.
• Proven experience leading data quality and data hygiene initiatives in regulated systems, including establishing data standards, remediation of data issues and establishment of sustainable data quality controls.
• Demonstrated experience contributing to and owning Quality 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 projects
• Experience with Agile methodologies and software development lifecycle processes
• Experience supporting or integrating additional Quality platforms (e.g., LIMS, MES, CMMS, LMS)

#LI-LJ1 #LI-remote U.S. Pay Range $135,400.00 - $183,200.00 The pay range reflects the full-time reputed company salary range 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). Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision 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 paid time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam 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 bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, 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 factor protected by federal, state, or local law. Alnylam is an E-Verify Employer. Apply tot his job Apply To this Job