Enterprise Architect

Indegene Inc.; India; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Indegene Inc. is seeking an experienced Enterprise Architect to lead the design and evolution of our technology landscape in a regulated pharmaceutical environment.

The role balances strategic vision with tactical execution to support R&D, clinical trials, manufacturing, quality, and commercial operations while complying with global regulatory standards. You will define the enterprise architecture roadmap and ensure data integrity, standardize platforms, and collaborate with QA during audits.

Qualifications

• Extensive regulatory knowledge for pharma environments.
• Experience with TOGAF and enterprise architecture frameworks.
• Experience with pharma systems and validated environments.
• Deep understanding of data integrity, validation, and quality systems.
• Ability to balance innovation with regulatory constraints.

Responsibilities

• Define and maintain the enterprise architecture vision and roadmap aligned with pharma business goals (R&D, clinical, manufacturing, supply chain).
• Ensure compliance with global regulations including GxP, FDA 21 CFR Part 11, and Annex 11.
• Drive digital transformation initiatives (lab digitization, smart manufacturing, real-world evidence platforms).
• Define enterprise data strategy ensuring data integrity (ALCOA+), governance, and traceability.
• Standardize platforms across functions (LIMS, ERP, MES, Clinical systems).
• Collaborate with QA and regulatory teams during audits and inspections.

Skills

Regulatory knowledge

TOGAF

Pharma systems

Data integrity

Innovation vs compliance

Education

TOGAF Certification

Cloud (AWS/Azure)

Pharma/Life sciences experience

Tools

LIMS

ERP

MES

Clinical systems

Job description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology.

Looking to jump-start your career?

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth.

Job Summary. We are seeking an experienced Enterprise Architect to lead the design and evolution of our technology landscape in a regulated pharmaceutical environment. This role balances strategic vision with tactical execution, ensuring IT systems support R&D, clinical trials, manufacturing, quality, and commercial operations while complying with global regulatory standards.

We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Key Responsibilities

• Define and maintain the enterprise architecture vision and roadmap aligned with pharma business goals (R&D, clinical, manufacturing, supply chain)
• Ensure compliance with global regulations including GxP, FDA 21 CFR Part 11, and Annex 11
• Drive digital transformation initiatives (e.g., lab digitization, smart manufacturing, real-world evidence platforms)
• Define enterprise data strategy ensuring data integrity (ALCOA+), governance, and traceability
• Standardize platforms across functions (e.g., LIMS, ERP, MES, Clinical systems)
• Partner with business and quality leadership to align IT investments with regulatory and operational priorities
• Establish architecture governance, validation strategy, and risk management frameworks
• Evaluate and adopt emerging technologies (AI/ML in drug discovery, IoT in manufacturing, cloud for clinical data)
• Enable interoperability across systems using standardized integration patterns and APIs
• Translate business and regulatory requirements into validated solution architectures
• Ensure all systems are developed and maintained in compliance
• Support implementation teams with architecture guidance and validation documentation
• Conduct architecture reviews, risk assessments, and impact analysis for system changes
• Oversee system integration ensuring traceability and compliance across data flows
• Collaborate with QA and regulatory teams during audits and inspections
• Resolve complex technical and compliance-related challenges during delivery

Key Skills & Competencies

• Strong knowledge of pharma regulatory frameworks and compliance requirements
• Expertise in enterprise architecture frameworks (e.g., TOGAF)
• Experience with pharma systems
• Deep understanding of data integrity, validation, and quality systems
• Ability to balance innovation with compliance constraints

Qualifications

• 12+ years of IT experience, with 3–5 years in enterprise/solution architecture
• Proven experience in pharmaceutical, life sciences, or regulated industries
• Certifications: TOGAF, cloud (AWS/Azure), or pharma compliance certifications preferred
• Familiarity with AI/ML use cases in drug discovery or manufacturing

Key Outcomes

• Fully compliant and audit-ready IT landscape
• Reduced compliance risks and successful regulatory inspections
• Standardized and validated system architecture across functions
• Improved data integrity, traceability, and reporting accuracy

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.