Company overview: TraceLink s software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance, visibility, and decision making. It reduces disruption to the supply of medicines to patients who need them, anywhere in the world. Founded in 2009 with the simple mission of protecting patients, today Tracelink has 8 offices, over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT. Tracelink is recognized as an industry leader by Gartner and IDC, and for having a great company culture by Comparably. Position Overview TraceLink is looking for experienced German-speaking Market Development Representatives to join our Pune-based team. As a MDR you will work together with our global Business Management, Commercial Operations, and Sales team members to intensely research companies, qualify and mature TraceLink s inbound & outbound leads, and diligently engage prospects in order to organize meetings with Sales and Account Managers. Responsibilities Gather market intelligence and deeply research customer and prospect accounts through public and private data sources Qualify and score inbound leads to identify and prioritize key companies & personas for maximum campaign effectiveness Monitor public information sources to augment accounts, leads, and opportunities with data to enhance prospecting effectiveness Develop personalized strategies for using email, social media, and other channels to engage prospects to increase engagement rates Quickly follow up on marketing campaigns to create and maintain account intelligence briefs for Sales and Account Managers to prepare them for prospect and customer meetings Leverage teammates (Managers, and Sales & AMs) to develop targeted lists, call and email strategies, and messaging to drive opportunities and prospecting activities Work with partners including Finance, Marketing & Sales Operations, and Business Management to enrich, cleanse and triage account data Engage with functions such as Business Management, Marketing, and Sales to understand business priorities Document activity in Salesforce and report qualitative and quantitative results on a weekly basis Qualifications 2-5 years experience in Market Development, Business Development, or similar roles Ability to effectively research, qualify, and react to leads and business opportunities BA/BS or equivalent graduation education. Experience with Salesforce.com, Marketo, or similar applications Excellent knowledge of MS Office (Outlook, Word, PowerPoint, and Excel). Precise, professional communication style through both written and verbal channels Professional, empathetic manner capable of managing time and prioritizing tasks effectively with autonomy Proven experience working closely with cross-functional teams Ability to work in a fast-paced international start-up environment

Assist the Regulatory and Quality Compliance (RQC) team to ensure compliance with TraceLink procedures and relevant global regulations and standards (ISO 9001, FDA 21 CFR Part 11, EU Annex 11), and to ensure ISO certifications are maintained. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Improve quality management system processes, especially related to training, document management, records management, internal auditing, and KPI reporting. Responsibilities Ensure the company s products and services organizations are compliant with relevant government and industry regulations including but not limited to: ISO 9001, US FDA 21 CFR Part 11, and EU Annex 11 for the development and maintenance of regulated software products and related services Manage revision and approval of the Quality Management System (QMS) documents, including but not limited to periodic SOP reviews, change control, document management system (eQMS), control of records, electronic signatures, and good documentation practices Perform internal quality audits of the organization, including authoring plans and reports, tracking findings, and follow up Assist with management of the QMS employee training program, compliance monitoring, eLMS system, and continual improvement efforts Assist with Corrective and Preventive Action (CAPA) investigations, root cause analysis, and authoring reports Maintain metrics / Key Performance Indicators (KPIs) for operational effectiveness monitoring of key department functions Assist with internal tool assurance activities including annual inventory reviews in collaboration with system business owners, periodic reviews, risk assessments, and performing tool validation/qualification where required Interface with RQC management, and all levels of functional management throughout the corporation to create, implement, improve, and monitor quality practices and procedures in accordance with corporate Quality Management System (QMS) Support software approval, release, and deployment activities, as needed and on a rotating basis Stay abreast of industry and federal regulations and standards that inform the QMS including ISO 9001, Part 11/Annex 11, GAMP5, data integrity, and software validation/assurance Provide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision making Skills and Qualifications Essential BA/BS in engineering, computer science, information systems, or other scientific discipline General knowledge of the life sciences / healthcare / pharmaceutical industries, drug supply chain management, computer system validation, and/or medical devices Demonstrated knowledge of ISO 9001 or similar standards 4-6 years performing or managing quality, audit, and/or software validation/qualification activities within the pharmaceutical, medical device, clinical trial, or other related industry Familiarity with cloud-based software, agile software development, and automation. Ability to work independently and as a team member in fast-paced environment, in an effective and flexible manner Highly developed and proven written and verbal communication skills Strong interpersonal skills to be able to build trust and relationships with cross-functional teams, challenge constructively, and collaborate and deliver results as a team. Desirable Experience with global teams across time zones and geographies Familiarity with US FDA 21 CFR 820/211, FDA Computer Software Assurance (CSA), GAMP5 Experience with Medical Devices, Data Integrity, Data Privacy, Artificial Intelligence (AI)

This position is responsible for defining and improving TraceLink s practices related to quality assurance and providing strategic and tactical leadership, and technical guidance. This position will work across multidisciplinary teams to ensure software solutions for our cloud-based platform are delivered with the highest quality. Responsibilities Provide thought leadership on how to improve our quality processing covering the entirety of the software development process Drive TraceLink s approach to automated testing to ensure that code can be effectively and efficiently tested across all types of tests - regression, integration, performance, chaos, smoke, etc. Provide oversight and technical guidance to build and maintain TraceLink s test automation and performance framework Drive chaos engineering initiatives to proactively test and improve application resilience in complex distributed systems Drive the creation of real-time dashboards for quality and performance metrics, enabling proactive decision-making on release readiness. Continuously refine QA and testing processes to align with evolving regulatory and industry standards, ensuring a best-in-class software delivery lifecycle. Integrate real-world use cases and customer feedback loops into test strategies to prioritize the most critical and high-impact scenarios. Document the Standard Operation Procedures (SOPs) and Standards as part of TraceLink s formal Software Development Lifecycle (SDLC) processes. Identify and track metrics to determine the readiness of a software release for customer-facing environments (validation and production). Leverage industry standards and best practices for software development quality engineering and assurance within an agile environment Coach and mentor QA teams, fostering a culture of quality ownership across engineering, DevOps, and product teams Skills and Qualifications Bachelor s degree or foreign degree equivalent in Computer Science, Computer Engineering, or related field and 8 years of post-baccalaureate experience working in a software development-related occupation 8-10 years of experience managing and growing Software Quality Assurance operations across cross-functional teams 8-10 years of experience working with the Software Development Life Cycle (SDLC), Quality Assurance, and Test Methodologies 4+ years of experience working in an Agile development environment 8-10 years of experience working with modern testing methodologies and techniques such as Agile, CI /CD, and Continuous testing on cloud-based platforms such as AWS 4+years of experience balancing structure, process, risk management, and time-to-market factors 4+years of experience in deploying and maintaining highly scalable applications on AWS 5-8 years of experience in at least one commercial programming language such as Python or JAVA 8-10 years of experience in building and maintaining test automation frameworks 5+ years of experience in building and managing performance testing frameworks 4 years of experience in documenting development and testing procedures within a formal development environment with a well-documented SDLC. An environment-building software to operate within a GxP environment is preferred Experience testing microservices in containerized environments (e.g., Docker, Kubernetes), including service discovery, load balancing, and resilience. Familiarity with security testing best practices, such as penetration testing and vulnerability scanning. Helpful to hace experience in a GxP industry Ability to design and maintain robust strategies for generating, managing, and anonymizing test data to ensure comprehensive and compliant test coverage. Proficiency with API testing frameworks (e.g., REST Assured, Postman, SoapUI) and integration testing in complex, multi-service environments. Excellent communication skills; experience engaging with both internal and external customers

The Software Engineer I is responsible for the design, development and maintenance of microservices that interface with data at a large scale, as well as all related activities within the application development process. You will: Develop software that takes best advantage of our cloud-based fully-distributed architecture Provide architectural input for software development efforts utilizing a good understanding of various technologies such as web applications, relational and NoSQL databases, information security, cloud-based services, etc. Provide high-level analysis and design reviews to apply appropriate technologies and architecture to solve conceptual problems; ensure design, structure, and content meet performance guidelines Research and remain informed of new technologies and tools, and how such technologies could be applied at TraceLink; recommend extension, expansion, and update of technology standards, practices, and methodologies Actively participate in all phases of the software development lifecycle Collaborate with product owners, other product stakeholders, and team members Review and analyze current systems and processes, matched against user needs and business requirements to determine technical requirements Accurately estimate tasks, and hit those estimates and provide regular status updates as part of our scrum-based Agile development process Work closely with our QA team; assist with test planning as appropriate Integrate 3rd party components as appropriate Candidates must possess the following skills and traits: 1-3 years of software development experience Experience in software development in Java (preferred), JavaScript or similar languages Experience in developing web services and web-based APIs Experience in building cloud-based applications on platforms such as Amazon Web Services Experience with microservices architecture, NoSQL and RDBMS databases, REST architecture, JSON, Docker-based deployment, Dropwizard or similar framework Experience in database design and working with very large data sets Experience with software development best practices: version control, defect tracking, unit testing, etc. Ability to communicate effectively and clearly, and collaborate with other disciplines Self-motivated, results-oriented and comfortable setting and meeting deadlines Proven experience in debugging complex issues BS in Computer Science or equivalent Helpful skills and experience: Experience developing a product in an Agile development environment Experience with Amazon AWS deployment and services Experience with distributed computing architectures Experience in large-scale, distributed database systems Experience with NoSQL architectures Experience in developing Enterprise Software (e.g. Supply Chain, ERP, Manufacturing) Experience with the pharmaceutical industry