Merck Gruppe - MSD Sharp & Dohme
Senior Specialist, Vault Quality Support Engineer
Merck Gruppe - MSD Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
R3: Senior Manager, Vault Quality Support Engineer
The Opportunity MSD 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 Provide operational and technical support for the Veeva Vault Quality platform.
Collaborate with Quality, Compliance, and IT teams to ensure smooth functioning of Veeva Vault applications.
Assist in maintaining and enhancing the Vault environment to meet business and regulatory requirements.
Key Responsibilities
Support day-to-day operations of Veeva Vault Quality modules (e.g., QualityDocs, QMS, Audit, Issues, Inspections, Complaints, Change Control).
Troubleshoot and resolve user issues related to Vault Quality applications.
Manage user access, roles, and permissions within Veeva Vault.
Assist in configuration and administration of Vault workflows, lifecycles, and metadata.
Coordinate with Veeva Vault administrators and external vendors for system upgrades, patches, and validations.
Generate reports and dashboards to support Quality Operations metrics and KPIs.
Participate in system validation activities, including test case creation, execution, and documentation.
Provide support materials to end-users to improve adoption and compliance.
Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GxP) in system operations.
Document processes, SOPs, and support tickets related to Vault Quality Operations.
Required Skills and Qualifications
Experience with Veeva Vault Quality (Quality Docs & QMS).
Strong understanding of Quality processes such as Deviations, CAPA, Change Control, Document Management, Complaints and Audits.
Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.
5+ years in technical support, tooling/platform support, or system administration.
Knowledge of regulatory requirements relevant to pharmaceutical/biotech industries.
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.
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The Opportunity MSD 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 Provide operational and technical support for the Veeva Vault Quality platform.
Collaborate with Quality, Compliance, and IT teams to ensure smooth functioning of Veeva Vault applications.
Assist in maintaining and enhancing the Vault environment to meet business and regulatory requirements.
Key Responsibilities
Support day-to-day operations of Veeva Vault Quality modules (e.g., QualityDocs, QMS, Audit, Issues, Inspections, Complaints, Change Control).
Troubleshoot and resolve user issues related to Vault Quality applications.
Manage user access, roles, and permissions within Veeva Vault.
Assist in configuration and administration of Vault workflows, lifecycles, and metadata.
Coordinate with Veeva Vault administrators and external vendors for system upgrades, patches, and validations.
Generate reports and dashboards to support Quality Operations metrics and KPIs.
Participate in system validation activities, including test case creation, execution, and documentation.
Provide support materials to end-users to improve adoption and compliance.
Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GxP) in system operations.
Document processes, SOPs, and support tickets related to Vault Quality Operations.
Required Skills and Qualifications
Experience with Veeva Vault Quality (Quality Docs & QMS).
Strong understanding of Quality processes such as Deviations, CAPA, Change Control, Document Management, Complaints and Audits.
Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.
5+ years in technical support, tooling/platform support, or system administration.
Knowledge of regulatory requirements relevant to pharmaceutical/biotech industries.
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.
#J-18808-Ljbffr