Job Description

The Senior Specialist Veeva Quality Platform Configuration will have advanced experience in Veeva technology, architecture, specifically Vault Quality configuration and will be responsible for the assessment and design of new functionalities, enhancements and will play critical role in executing system configurations within Vault Quality. This role is essential part of Quality Platform team to assure delivery of product enhancements according to the Product and Platform Roadmap.

Key Responsibilities:

Solutioning and design of new functionalities and enhancements

Executing system configurations

Provide expertise in Veeva Quality suite as a certified Vault platform administrator and QMS system administrator and configuration specialist.

Drive technical impact assessment activities, reviewing proposed changes and ensuring impact understood across VQMS and QualityDocs.

Participate on system qualification activities (IQ/OQ, system and regression testing) including documentation

Deliver product enhancements through agreed backlog process to ensure Veeva Vault Quality evolves to meet business needs.

Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts

Collaborate across teams and work closely with Veeva Platform application owners, Product owners and IT Architects

Collaborate with Veeva Enterprise Managed Services on product features

Manage and maintain meta data in Quality Vault (picklists, organizational data, etc)

Knowledge/Education Required:

Minimum Level of Education Required - Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background on how Information Technology supports the delivery of business objectives

Preferred Level of Education - Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.

Minimum Level of Job-Related Experience Required - 4+ year of Veeva Vault Quality experience and particularly desirable is QMS experience. Veeva Quality Docs and QMS is a Validated SAAS application, and therefore documented certification and experience of working in a GxP environment is required.

Preferred Experience and Skills:

Experience in information technology and relevant business areas

Understanding of Quality Management System Capabilities (Audit/Inspections, Change Control Deviations , Complaints, Supplier Quality and Risk Management)

As knowledge of Veeva Quality Suite grows, more advanced configuration and integration work is expected. This knowledge will be used on a daily basis as part of configuration work, handling changes requests and will ultimately support business processes across Manufacturing and R&D.

Experience in solution delivery with GMP systems

Experience with architecture, integration, interfaces, portals, and/or analytics

Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes

Experience in an Agile environment

What we need from you to be successful in this role:

Problem solving skills are required to solve business process issues identified in the backlog.

Additionally, the candidate may identify problems with the product and should be sufficiently skilled to confidently propose solutions

The candidate must not only understand the current configuration, but also look to best practices to best solve any new enhancements without impact on any other workflows that may share objects.

Written and verbal communication skills including the ability to communicate with both a business and a technical audience.

The ability to work independently and effectively as a team across global hubs, and maintain a highly collaborative, transparent effort.

Demonstrated ability to solve problems with a sense of ownership, enthusiasm, and innovation

Ability to work in a global, multi-cultural, English-speaking environment

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs

Preferred Skills:

Job Posting End Date:

01/31/2025

*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.

Requisition ID:R327291