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Job Description
- Role Overview:
You will be a Technology Compliance Partner in Animal Health R&D IT, responsible for reviewing & rewriting SDLC documents and providing SDLC advice to IT colleagues and business regarding the practical application of the SDLC. Your 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:
- 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 the IT Control Requirements Set including the adoption of agile ways of working.
- Provide Regulatory advice regarding requirements that include GLP, GMP, GCP as most of our systems are part of a regulated process.
- Make balanced decisions based on risk input from the product teams.
- Provide compliance advice to IT colleagues regarding the practical application of the SDLC for product teams.
- Support efforts to reduce SDLC documentation through automation and pipeline delivery.
- Advance Agile SDLC competency and drive good practices for product teams.
- Work across product teams and initiatives as subject matter expert on the SDLC and IT compliance controls.
- Maintain a customer-centric focus on compliance to drive a consistent approach across IT.
- Coordinate and prioritize the work through agile principles.
- Support team members with complex questions, review and adjust their work where needed.
- Write and review SDLC documentation according to our company's standards.
- Assist in collecting information for Change Control and addressing impact changes for application releases.
- Ensure that the IT organization operates and complies with established policies/procedures.
- Support audit/inspection readiness and participate in the timely review and Corrective and Preventative Action (CAPA) response.
- Monitor IT compliance indicators, evaluate impacts, and ensure non-compliance incidents are communicated and actioned.
- Oversee policies, SOPs, supporting documents, and associated materials to ensure seamless integration with other processes.
- Work within a matrix organizational structure, reporting to both the functional manager and the project manager.
Qualifications Required:
- Bachelor's degree in Computer Science, Information Technology, Law, or a related field.
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- 7+ years of experience in technology compliance, risk management, or a related field.
- Strong knowledge of data protection laws and regulations (e.g., GDPR, Annex 11).
- Understanding and experience in System Development Life Cycle, good engineering practice, and computer validation (CSV & CSA).
- Excellent analytical and problem-solving skills.
- Excellent verbal and written communication skills to convey risk findings and recommendations.
- Excellent integrity, ability to stand up to protect our company.
- Ability to communicate complex compliance issues to non-technical stakeholders.
- Meticulous attention to detail to ensure accurate risk assessments and reporting.
- Understanding of relevant regulations and compliance standards.
- Ability to manage risk-related projects and coordinate with various teams.
- Strong organizational skills to handle multiple tasks and priorities effectively.,
Skills
ManagementConsultantReportingInformation SecurityComputer System Validation CSVProcess DevelopmentTechnical AdviceIT Risk ResponsePolicyIT Risk AssessmentsStakeholder ManagementIT Risk GovernanceQuality ManagementControl MonitoringKnowledge Of RegulationsData ManagementFrameworksIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
About Company
MSD, known as Merck & Co., Inc. in the United States and Canada, is a leading global biopharmaceutical company that has been at the forefront of research and innovation in healthcare for over a century. Headquartered in Kenilworth, New Jersey, MSD is dedicated to producing medicines, vaccines, biologic therapies, and animal health products that address some of the most urgent and challenging health issues facing the world today. With a firm commitment to improving global health, MSD operates in more than 140 countries, offering solutions across a wide range of areas including oncology, infectious diseases, cardiovascular health, and diabetes. Through cutting-edge research and development, MSD continues to pioneer new pathways for treating and preventing illness, striving to make a significant impact on people's lives around the globe.
Important dates & deadlines?
Application Deadline
02 Nov 25, 01:04 PM IST
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Senior Manager, Technology Compliance
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