Description

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 implement QMS technical solutions to meet business requirements.

Oversee all technical delivery for QMS and backup the technical owner of the system(s).

Define and implement IT application standards, ensuring alignment with global IT and industry best practices for software development and system implementation.

Contribute and help manage the 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 for application integrity, making informed recommendations to minimize unnecessary customization and preserve system purpose.

Execute a 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 with 8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems with a preference for experience with ETQ, IQVIA and the Force.com platform.

What else we look for (Preferred):

Experience working with 21 CFR part 820.

Experience working in a regulated environment, and strong understanding of concepts 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 in server-client and/or web hosted application architecture and integrations via API’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 3rd party 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 mindset with an excitement to learn new technologies.

Have a passion for our mission at Edwards Lifesciences.

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Architect, IT Solutions(QMS)

Description

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