Associate. Director, Technology Compliance

MSD

Hyderabad

On-site

INR 3,500,000 - 7,000,000

Full time

18 hours ago

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Job summary

MSD in Hyderabad seeks an Associate Director, Technology Compliance to lead governance, risk, and compliance for R&D IT. You will embed compliance into SDLC, DevOps, and validation, ensuring regulatory alignment and inspection readiness across digital delivery.

You will guide IT controls, risk profiling, and documentation while coordinating audits with product, engineering, and site leadership, including Hyderabad. A senior specialist with 10+ years in life sciences IT compliance is expected.

Qualifications

Bachelor's degree or equivalent qualification in a life sciences or IT field.
10+ years IT compliance experience in life sciences or pharma industry.
Strong knowledge of GxP, GLP/GMP, and 21 CFR Part 11.
Experience leading and coaching teams and audits.
Practical guidance for technical, product, and project teams.

Responsibilities

Lead governance, risk, and compliance for R&D IT across SDLC and DevOps.
Embed compliant practices in digital delivery and validation lifecycle management.
Oversee IT validation activities and ensure regulatory alignment and inspection readiness.
Manage compliance risks, CAPA, and remediation with root cause analysis.
Coordinate audits, inspections, and regulatory reviews with stakeholders.

Skills

IT Compliance

GxP Knowledge

Regulatory Frameworks

SDLC Governance

Risk Management

Quality Management

Audits & Inspections

Stakeholder Management

Information Security

Education

Bachelor's degree or equivalent qualification

Job description

Associate Director, Technology Compliance R&D IT

Based in Hyderabad, join a global healthcare biopharma company and be part of a 130-year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Role Overview

The Associate Director, Technology Compliance leads governance, risk, and compliance within R&D IT, ensuring technology products, services, and processes meet internal policies and external regulatory obligations.

The role serves as a strategic advisor to IT leadership, product, engineering, and service teams, embedding compliance into digital delivery while maintaining inspection readiness and strong risk management practices.

What You Will Do

Leadership & Stakeholder Management

Lead, coach, and develop the R&D IT compliance team.
Serve as a member of the R&D IT Management Team.
Act as the key compliance contact for R&D IT employees and site leadership, including Hyderabad where applicable.
Promote knowledge sharing, capability building, and consistent compliance practices across the organization.
Technology Compliance & Advisory
Advise product, engineering, and service teams on SDLC, digital SDLC, eVal, IT controls, compliance risk profiling, and documentation practices.
Embed compliant Agile and DevOps ways of working across R&D IT.
Oversee IT validation lifecycle activities, including planning, execution, reporting, and documentation management.
Ensure computerized systems are validated in line with applicable GxP requirements.
Risk Management & Remediation
Identify, assess, and manage IT compliance risks across systems and processes.
Lead remediation activities, including root cause analysis, corrective actions, and follow-up.
Implement consistent risk management practices and compliance reporting.
Monitor the validated state of GxP-relevant systems through periodic reviews.
Compliance Processes & Quality Management
Own key IT compliance processes, including SDLC, CAPA, personnel qualification, IT regulatory control services, and independent compliance monitoring.
Ensure policies, SOPs, and supporting documentation are current, integrated, and practical to use.
Drive continuous improvement of quality systems and compliance practices.
Align global SDLC standards with local GxP requirements and Agile/DevOps delivery models.
Audit & Inspection Readiness
Ensure continuous inspection readiness across R&D IT.
Lead preparation for internal and external audits and regulatory inspections while collaborating with the GLP IT responsible persons at the sites.
Oversee audit execution, including evidence collection, risk identification, reporting, CAPA definition, and follow-up.
Provide expert guidance during inspections and regulatory interactions.
Lead or oversee vendor and system-level audits focused on validation and compliance.
Ensure third-party platforms meet applicable regulatory validation expectations.
Governance & Oversight
Implement and maintain governance frameworks aligned with organizational values and regulatory expectations.
Monitor IT compliance indicators and ensure timely communication and resolution of non-compliance incidents.
Act as the primary interface with regulatory authorities and external stakeholders where appropriate.
Lead independent reviews of governance practices and recommend improvements.

Key Stakeholders

R&D IT Leadership Team
R&D Business stakeholders.
R&D IT Compliance Team
Product, Engineering, and Service Teams
Quality Assurance and Regulatory Affairs
Site Leadership, including Hyderabad where applicable
External Auditors and Regulatory Authorities

What Should You Have

Bachelor’s degree or equivalent qualification required.
Minimum of 10 years of IT compliance experience in the life sciences industry.
Experience leading, coaching, and developing people or teams.
Deep knowledge of GxP regulations, including GLP and GMP, and computerized system regulations such as 21 CFR Part 11.
Strong knowledge of digital SDLC, validation lifecycle management, IT controls, and quality management principles.
Expertise in identifying, assessing, managing, and reporting technology compliance risks.
Proven experience preparing for and supporting audits, inspections, and regulatory reviews.
Ability to provide practical compliance guidance to technical, product, and project teams.
Strong collaboration skills across teams, functions, and locations.
Excellent written and spoken English communication skills.

Primary Skills

Strong experience within the Pharmaceutical/Biopharmaceutical industry.
Proven experience in IT Compliance.
Strong understanding of regulated environments and compliance frameworks

Who We Are

We are known as well-known org Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What We Look For

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Required Skills

Control Monitoring, Corrective Action Management, Data Management, Identifying Risks, Information Security, IT Compliance Management, IT Governance, IT Governance Risk and Compliance (GRC), IT Operation, IT Performance Management, IT Risk Assessments, IT Risk Governance, IT Risk Response and Reporting, IT Security Compliance, Knowledge of regulations and frameworks, Policy and process development, Quality Management, Regulatory Reviews, Risk Management, Risk Monitoring, Security Risk Analysis, Stakeholder Management, Technical Advice

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License