Architect, IT Solutions(QMS)

Edwards Lifesciences Belgium; Pune District; On-site; INR 4,500,000 - 7,000,000; Full time

Job summary

Edwards Lifesciences in Pune, India is launching a new IT Innovation Hub and seeks an IT Application Architect, QMS, to lead design and implementation of enterprise quality management systems. You will work with global quality teams to evolve QMS platforms, ensure compliance, and drive modernization through ETQ, IQVIA and Force.com initiatives.

You will partner with business leaders and IT to manage platform roadmaps, address security vulnerabilities, and advance remediation of technical debt

Qualifications

• Bachelor's degree with 8+ years of hands-on QMS experience.
• Experience with ETQ, IQVIA, and Force.com platform.
• Knowledge of 21 CFR part 820 and regulated environments.
• SQL and relational database familiarity; API integrations.
• Ability to communicate with senior leadership and drive roadmaps.

Responsibilities

• Design and implement QMS technical solutions to meet business needs.
• Oversee all technical delivery for QMS and support the system owner.
• Define IT application standards aligned with best practices.
• Contribute to and manage platform roadmaps; address security issues.
• Remediate technical debt and enable scalable enterprise solutions.
• Partner with leaders to assess implementation complexity for initiatives.
• Act as steward for application integrity and minimize unnecessary customization.
• Shift-left support strategy; retain L3 while moving L2 to global team.

Skills

QMS design and implementation

Regulatory mindset

Executive communication

ETQ IQVIA Force.com familiarity

Education

Bachelor's degree in a technical field

Tools

ETQ

IQVIA

Force.com

SQL

API integrations

Job description

India-Pune

Full time

Req-49947

Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working in close partnership with teams across regions to deliver reliable, high-quality solutions at scale.

Designed as a long-term investment, the Pune Hub will advance newer digital capabilities such as automation, data, AI, and cloud, and will include roles spanning end user services, application development, and enterprise platform teams.

Together, these teams will help Edwards operate more efficiently

and accelerate innovation in support of our mission of advancing patient care.

The IT Application Architect, Quality Management Systems (QMS), will serve as a key technical contributor for our enterprise quality management systems reporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Application Architect, QMS, you will be a key member of a global quality technical transformation team implementing and guiding the technical evolution and optimization of our QMS platforms across a global organization.

How will you make an impact:

• Design and implementQMStechnical solutions to meet business requirements.
• Oversee all technical delivery forQMSandbackup thetechnicalownerof the system(s).
• Define and implement ITapplicationstandards, ensuring alignment with global IT and industry best practices for software development and system implementation.
• Contribute and help managethe technical platform roadmap(s), including regular platform updates and prompt resolution of IT security vulnerabilities within established SLAs.
• Advocate for remediation of technical debt and continuous system improvements to drive business growth and development.
• Partner with business leaders to understand organizational needs and assess implementation complexity for both in-house and project-funded initiatives.
• Act as a steward forapplicationintegrity, making informed recommendations to minimize unnecessary customization and preserve system purpose.
• Executea shift-left strategy for support and maintenance, transferring Level 2 (L2) support to the global team while retaining Level 3 (L3) support, problem management, and change management within the transformation team.

What you'll need (Required):

• Bachelor's degree with8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprisequality management systems with a preference for experience with ETQ,IQVIAand the Force.com platform.

What else we look for (Preferred):

• Experience working with 21 CFR part820.
• Experience working in a regulated environment, and strong understanding ofconcepts and regulatory compliance in a pharmaceutical/medical device setting.
• Experience with commercial off the shelf applications and a solid understanding of the importance master data structure plays in a scalable enterprise solution.
• Experience writing and executing validation deliverables (e.g.,IQ/OQ/SDD) in the software development life cycle (SDLC) for validated, regulated, applications.
• Strong background inserver-client and/or web hostedapplicationarchitectureandintegrationsviaAPI's.
• Experience with server administration required to support an enterprise application.
• Experience with structured query language (SQL)and relational databases.
• Experience working with application vendors, and 3rdparty consulting companies on technology implementations and delivery.
• Comfortable communicating and presenting ideas/recommendations to a senior leadership level.
• Experience working in a global, highly matrixed, and team-oriented IT environment.
• High energy, self-motivation, and results-driven mindsetwith an excitement to learn new technologies.
• Have a passion for our mission at Edwards Lifesciences.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.