Job Description
Job Purpose:
This role is positioned within the Veeva Quality Platform Team as part of the Manufacturing Division in global IT hub in Prague, responsible for contributing to the technical solution design, implementation, and continuous improvement of the Veeva Quality Suite with specific alignment to the Quality business processes.
The QMS Veeva Technical Lead will have advanced experience in Veeva technology, architecture, specifically Vault Quality configuration and integrations and will play critical role in technical design and future vision assuring system scalability and adoptability to satisfy business needs, subject matter expertise to fellow team members. The individual would play critical role in technical ownership of Veeva Vault Quality.
Oversee advanced configuration changes on lifecycles, workflows, atomic security settings, objects, reports, etc.
Responsible for documenting technical changes following standards of Our Company.
Participate in designing the strategy for System validation and testing of any development work to assure compliance with regulatory and company standards.
Participate in Veeva Releases for Impact analysis and enabling functionality.
Expertise in the life sciences industry, specifically Quality Management Systems and technology landscapes; Vault Quality Architecture and system integrations. Knowledge of GxP.
Strong communication skills.
Experience of being part of an Agile team, working with cross-functional teams, managing customer expectations, and helping to drive best practices
Ensure that the Standard Processes of Our Company are applied and adhered to including embedding and adopting standard ways of working in accordance with Regulatory and Validation Guidelines.
Key Responsibilities :
Technical Oversight of Our Company’s Veeva Vault Quality
Provide Product expertise in Veeva Quality suite as a certified Vault platform administrator and QMS system administrator and configuration specialist.
Manage configuration changes for Vault Quality per agreed priority backlog items in JIRA.
Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood across QMS and QualityDocs.
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 the Manufacturing IT & R&D IT Quality teams and work closely with Product Manager and Veeva Platform Lead, IT Architects, and Value/Product Line teams
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 – 3+ 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 IT Quality and relevant business areas
Understanding of Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management)
As knowledge of Veeva Quality Suite grows, more advanced configuration 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 to the Product Manager and if required work with the Vendor.
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
What we offer
Competitive salary
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Representative office
Wide range of benefits
Flexible working hours, home office
Yearly Bonus based on company and personal performance
Pension and health insurance contributions
Edenred Benefits + meal vouchers
Internal reward system – INSPIRE – with redeeming option as services, goods or vouchers
Up to date laptop and iPhone mobile device
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:
No relocation
VISA Sponsorship:
Travel Requirements:
10%
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
