Specialist: Technology Compliance

Job description

Job Description R2, Specialist: Technology Compliance The Opportunity Join a global biopharma company with a 130-year legacy and mission to achieve new milestones in healthcare. Be part of technology driven, data-led organization supporting a diversified portfolio of medicines, vaccines and animal health products. Work alongside passionate teams that use data, analytics and insights to drive decisions, and tackle some of the world’s greatest health threats. Our Technology Centers are globally distributed hubs that enable our digital transformation and business outcomes across IT. They bring together diverse teams to collaborate, share best practices, and deliver solutions that save and improve lives. This role is based at our Hyderabad Tech Center and follows a hybrid working model (3 days onsite, 2 days remote). Candidates are expected to reside within commuting distance of the Hyderabad office. Role Overview We are seeking a Computer System Validation (CSV) Specialist to ensure the adherence of our IT organization to established policies/procedures and regulatory requirements. As a key member of our compliance team, you will engage with IT practitioners and act as a consultant for the System Development Life Cycle (SDLC), Compliance Risk Profile, Digital SDLC, Good Documentation Practices, and IT Control Requirements Set including the adoption of agile ways of working. Furthermore, you will support audit/inspection readiness, participate in the timely review and Corrective and Preventative Action (CAPA) response, and monitor IT compliance indicators. What will you do in this role · Partner with IT product teams to provide practical SDLC and IT compliance guidance (Compliance Risk Profile, Digital SDLC, Good Documentation Practices, IT Control Requirements Set) · Advise on GxP regulatory requirements (GGLP, GMP, GCP) and their applications to IT systems · Support efforts to reduce SDLC documentation through automation and pipeline delivery · Drive Agile SDLC competency and drive good practices for product teams · Act as SME for SDLC controls and IT compliance supporting product teams across initiatives · Maintain a customer-centric focus on compliance to drive a consistent approach across IT · Write, simplify and review SDLC documentation aligned with company's standards · Assist in collecting information for Change Control and addressing impact changes for application releases. · Contribute to audit and inspection readiness by participating in the timely review and Corrective and Preventative Action (CAPA) response. · Monitors IT compliance indicators, evaluating impacts and ensuring non-compliance incidents are addressed. · Drive a customer-centric, consistent compliance approach across IT · Oversees policies, SOPs, and supporting documents to ensure seamless integration with other processes. · Work effectively within a matrix organization, reporting to both the functional manager and the project manager. What should you have · Bachelor's degree in Computer Science, Information Technology, Law, or a related field · 3-7 years of experience in technology compliance, risk management, or a related field Primary skills (must-have) · Strong knowledge of data protection laws and regulations (e.g., GDPR, Annex 11). · Experience with the SDLC, good engineering practices, and computer validation (CSV & CSA) · Ability to perform accurate risk assessments, coordinate risk‑related projects, and drive remediation activities across teams · Strong verbal and written communication skills to convey risk findings, recommendations, and complex issues to non‑technical stakeholders · Excellent analytical and problem‑solving skills with high attention to detail for accurate reporting and assessments Secondary skills (nice to have) · Exposure to compliance, risk, or project management tools and audit/CAPA processes · Experience coordinating with diverse teams (technical, compliance, legal, business) in a matrix organization Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been 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: Agency Liaison, Agency Liaison, Client-Centric, Complaints Investigation, Compliance Monitoring, Compliance Policies, Compliance Program Development, Compliance Reporting, Computer Science, Employee Communications, Engineering Practices, GMP Compliance, IT Compliance Management, IT Policies, Metrics Analysis, Personal Initiative, Policy Implementation, Policy Procedures, Project Management, Project Risk Assessments, Proper Documentation, Regulatory Communications, Regulatory Compliance Audits, Regulatory Compliance Consulting, Risk Assessments {+ 1 more} 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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 07/15/2026*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.