Associate. Director, Technology Compliance

Job Description

Associate Director, Technology Compliance R&D IT

The Opportunity

• 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.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's’ IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centres.

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

na

Job Posting End Date:

08/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.