Senior Specialist, CDS & SDMS, Project Manager

Job Description 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 organization 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 Centers. Role Overview: The Project Manager for the Empower/NuGenesis platform is responsible for planning, executing, and closing projects related to system implementations, upgrades, and enhancements in regulated (GxP) environments. They develop detailed project plans, manage timelines, and resources, and ensure alignment with business and technical objectives. The role coordinates cross-functional teams including Business, IT, QA, and laboratory operations, while managing risks, issues, and stakeholder communications. They also ensure all project deliverables meet validation and compliance requirements such as FDA 21 CFR Part 11 and support audit readiness. What you should have : Primary Skills : Project Manager, GxP, FDA 21 CFR Part 11, and computer system validation (CSV), Secondary: PMP, Empower/NuGenesis platform PMP or equivalent project mgmt certification preferred. •Bachelor's degree or equivalent and a minimum of 1 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. What you will do: • Expertise in managing full project lifecycles for the Empower/NuGenesis platform, including scope, schedule, and resource coordination across implementations and upgrades. • Demonstrate success in leading project management for global and cross-domain initiatives, including interactions with all stakeholders from contributors to executive governance. • Demonstrated success in working Agile and hybrid Agile/Waterfall dynamics in a regulated environment. • Strong understanding of GxP, FDA 21 CFR Part 11, and computer system validation (CSV) to ensure compliant, audit-ready deliverables. • Ability to identify, mitigate, and communicate risks while aligning Business, IT, QA, and laboratory stakeholders to keep projects on track. • Effective leadership and communication skills to drive cross-functional teams, manage vendors, and deliver clear status reporting to upper management, business, and technical audiences. • Experience in Waters Empower CDS and NuGenesis SDMS preferrable but not required. • Good understanding of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA)• •Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc. •Strong analytic, critical thinking and problem-solving skills •Attention to detail. •Self-motivated •Experience in Pharma Industry with knowledge of cGMP and Laboratory processes. •Good Communication Skills including fluency in English Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and 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. #HYDIT2025 Required Skills: Agile Environments, Animal Vaccination, Behavioral Coaching, Business, Business Process Analysis, Change Management, Digital Technology, Digital Transformation, GxP Compliance, Information Technology Operations, IT Infrastructure Management, IT Solution Delivery, Key Account Planning, Microsoft Teams, Organizational Communications, Portfolio Management, Process Improvements, Project Management, Project Planning, Server Hardware Configuration, Software Development, Stakeholder Communications, Systems Development Lifecycle (SDLC), Vendor Management, Work Coordination 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/17/2026 *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. Requisition ID: R400554