Senior Manager, Vault Quality Technical Analyst

Job Description

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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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.
  

Requisition ID:R369314