Senior Manager, Technology Compliance

Required Skills Audit Management Governance Management Quality Assurance QA Quality Management Risk Management Technical Advice Preferred Skills Current Employees apply Current Contingent Workers apply Secondary Language s Senior Manager Technology Compliance 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 As a Technology Compliance Partner you will be responsible for authoring SDLC documents and providing SDLC advice to IT colleagues regarding the practical application of the SDLC This role is vital for IT product engineering and service teams to understand and implement technology and process controls to meet the company s policy and regulatory obligations Key Responsibilities Act as a consultant and provide compliance advice to IT practitioners on the System Development Life Cycle SDLC Compliance Risk Profile Digital SDLC Good Documentation Practices IT Control Requirements and adoption of Agile methodologies Lead efforts to advance Agile SDLC competency and drive adoption of automation tools to streamline compliance documentation testing and delivery pipelines Write review and optimize SDLC documentation in line with company standards supporting automation to reduce manual documentation efforts Collaborate across product teams as a subject matter expert on SDLC and IT compliance controls maintaining a customer-centric approach to ensure consistent compliance practices Ensure the IT organization operates in compliance with established policies and procedures monitoring compliance indicators and managing non-compliance incidents effectively Organize and support internal and third-party audits providing oversight and managing post-audit corrective and preventative actions CAPA to ensure timely remediation Lead qualification and validation deliverables for SAP ERP systems including S4 HANA ensuring adherence to industry standards and regulatory requirements such as GxP and SOX Work within a matrix organizational structure reporting to both functional and project managers and collaborate globally to share best practices and optimize compliance processes Required Skills and Experience Bachelor s degree in computer science IT Law or a related field with 7 years of experience in technology compliance risk management or related areas Extensive experience in SAP ERP validation within regulated environments and strong expertise in Computer Systems Validation CSV In-depth knowledge of relevant regulations and standards including 21 CFR Part 11 EU Annex 11 FDA GxP SOX and data protection laws such as GDPR Solid understanding of System Development Life Cycle SDLC good engineering practices and computer validation Proven experience managing audits managing CAPA processes and driving remediation efforts Excellent analytical problem-solving and organizational skills to manage multiple priorities in a global high-pressure environment Strong verbal and written communication skills capable of explaining complex compliance issues to both technical and non-technical stakeholders Ability to manage risk-related projects and collaborate effectively across cross-functional and global teams Our technology teams operate as business partners proposing ideas and innovative solutions that enable new organizational capabilities We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation 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 inventing for life 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 today 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 10 17 2025 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