Senior Manager, Vault Quality Technical Analyst

Senior Manager Vault Quality Technical Analyst The Opportunity Our company is an innovative global healthcare leader committed to improving health and well-being in 140 countries around the world Our product categories include heart and respiratory health diabetes infectious diseases and women s health We continue to focus our research on conditions that affect millions of people around the world - diseases like Alzheimer s Diabetes and Cancer - while further expanding our strengths in areas such as vaccines and biologics We aspire to be the best healthcare company in the world and provide leading innovations and solutions for tomorrow Role Overview Act as a liaison between Quality Operations IT and business stakeholders to gather analyze and document requirements related to Veeva Vault Quality applications Drive process improvements and system enhancements to optimize the use of Veeva Vault for Quality Management Support the implementation and ongoing maintenance of Veeva Vault Quality modules aligned with regulatory and business needs Key Responsibilities Collaborate with Quality Compliance and IT teams to understand business processes and translate them into system requirements for Veeva Vault Quality Operations Gather analyze document and validate comprehensive business and functional requirements to support system enhancements upgrades and new implementations Analyze current Quality Operations workflows e g QualityDocs QMS Audit Issues Inspections Complaints Change Control and identify opportunities for automation or process improvement using Veeva Vault Support configuration and testing activities by creating test plans test cases and coordinating User Acceptance Testing UAT Facilitate communication between technical teams developers administrators and business users to ensure clear understanding of requirements and solutions Assist in change management activities including training material development user guides and conducting training sessions Monitor system performance and user feedback to recommend continuous improvements Ensure compliance with regulatory standards FDA 21 CFR Part 11 GxP in all system-related processes Maintain documentation such as business process maps requirement specifications and SOPs related to Veeva Vault Quality Operations Required Skills and Qualifications 4 years of Technical Analyst experience with Vault Quality Systems QualityDocs QMS Strong understanding of Quality processes including CAPA Change Control Document Management Complaints and Audits Experience gathering and documenting business and functional requirements Familiarity with system validation lifecycle and testing methodologies Experience using JIRA XRAY for test case management test execution reporting defect management within Agile environments Excellent communication and stakeholder management skills Ability to translate complex business needs into clear technical requirements Knowledge of regulatory requirements in pharmaceutical biotech or medical device industries Proficiency with process mapping and documentation tools Detail-oriented with strong analytical and problem-solving skills Preferred Qualifications Experience working directly with Veeva Vault or other cloud-based QMS platforms Veeva Certifications Veeva Vault Vault Quality Suite QMS The role holder has completed the Certified Vault Training and is up to date Background in regulated environments pharma biotech medical devices Experience with Agile or other software development methodologies Familiarity with reporting and data analysis tools Who we are We are known as Merck Co Inc Rahway New Jersey USA in the United States and Canada and MSD everywhere else For more than a century we have been inventing for life bringing forward medicines and vaccines for many of the world s most challenging diseases Today our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world Here you have that opportunity You can put your empathy creativity digital mastery or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time Our team is constantly evolving so if you are among the intellectually curious join us and start making your impact today HYDIT2025 Required Skills Data Engineering Data Visualization Design Applications Documentations Leadership Management Quality Control Management Quality Management Quality Management System Auditing Report Writing Senior Program Management Software Configurations Software Development Software Development Life Cycle SDLC Solution Architecture Supervisory Management System Designs Systems Integration Testing Vault Management Preferred Skills Current Employees apply Current Contingent Workers apply Search Firm Representatives Please Read Carefully Merck Co Inc Rahway NJ USA also known as Merck Sharp Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities All CVs resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place Where agency agreements are in place introductions are position specific Please no phone calls or emails Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material s Job Posting End Date 11 13 2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date Please ensure you apply to a job posting no later than the day BEFORE the job posting end date