Director - Process Analytics - Regulatory Affairs 3

Director - Process Analytics - Regulatory Affairs

Ready to turn bold ideas into real-world impact?

At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.

If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.

Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.

Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description

Responsibilities:

The SME will be responsible for Blueprinting of Quality

related processes for transitioning from Client sites to their

GCC in India. The scope will include

Develop understanding of As-Is process (at an L3

level), current SLAs / KPIs, and challenges / pain

points

Create global To-Be process maps using Visio

Understand country specific variation in processes

Incorporate country specific variation in Global To[1]Be Maps

Recommend and prioritize transformation

opportunities in the process

Recommend updated SLAs / KPIs

The process in scope includes (not exhaustive)

Quality Services – Batch record review, Lab System

support, QMS Analytics and Reporting

Supplier Audits

Sytem Offices – gLIMS, tLIMs

Regulatory Affairs - Product Safety, RA Services

Supplier Management – Supplier Lifecycle requests,

Material / Service VSCI Line, VCN assessment and

implementation

The SME is expected to work independently on the above

and lead discussions with the client.

Qualifications

Bachelors - Business Analytics, Bachelors - Computer Science, Bachelors - Statistics, Masters - Data Science

Certifications

Certified Internal Auditor (CIA) - TUV SUDTUV SUD

Required Skills

Regulatory Affairs Compliance

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Process Analytics - Regulatory Affairs

Remote Type -

Hybrid

Work Shift -

Day Job (India)

Why join Genpact?

Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter

Make an impact – Help global enterprises solve business challenges that matter

Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead

Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day

Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.

Let’s build tomorrow together.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.