Kathleen Declercq Email & Phone Number

𝗗𝘆𝗻𝗮𝗺𝗶𝗰 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗔𝗻𝗮𝗹𝘆𝘀𝘁 and 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗢𝘄𝗻𝗲𝗿 with a strong track record in leading compliance initiatives for the implementation of new systems within a validated Software Development Life Cycle (SDLC). Skilled in collaborating with stakeholders to define user requirements, GxP standards, and security user stories, and organizing comprehensive testing processes. Committed to ensuring alignment between technical solutions and business needs to facilitate successful project delivery.𝚑̲𝚘̲𝚠̲ ̲𝚌̲𝚘̲𝚕̲𝚕̲𝚎̲𝚊̲𝚐̲𝚞̲𝚎̲𝚜̲ ̲𝚍̲𝚎̲𝚜̲𝚌̲𝚛̲𝚒̲𝚋̲𝚎̲ ̲𝚖̲𝚎̲:̲• 𝗖𝗼𝗺𝗺𝗶𝘁𝗺𝗲𝗻𝘁 𝘁𝗼 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗦𝘂𝗰𝗰𝗲𝘀𝘀: Demonstrates unwavering dedication to achieving project objectives and ensuring timely delivery.• 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗮𝗻𝗱 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻: Proven leadership skills with a strong focus on fostering teamwork and collaboration among multidisciplinary teams to drive results.• 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗖𝗼𝗼𝗿𝗱𝗶𝗻𝗮𝘁𝗶𝗼𝗻: Proven ability to coordinate effectively within large multidisciplinary teams, facilitating collaboration and enhancing project success.• 𝗡𝗲𝗴𝗼𝘁𝗶𝗮𝘁𝗶𝗼𝗻 𝗦𝗸𝗶𝗹𝗹𝘀: Proficient in balancing business needs with regulatory requirements, ensuring compliance while meeting organizational objectives.• 𝗔𝗱𝗮𝗽𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆: Exceptional ability to manage shifting project priorities, demonstrating flexibility and responsiveness to changing demands.• 𝗖𝗮𝗹𝗺 𝗨𝗻𝗱𝗲𝗿 𝗣𝗿𝗲𝘀𝘀𝘂𝗿𝗲: Maintains composure and effectiveness in high-stress situations, enabling sound decision-making and problem-solving𝚂̲𝚔̲𝚒̲𝚕̲𝚕̲𝚜̲:̲Technology and business function:• Analytical & critical thinking• Domain knowledge, understand business (clinical trials)o Jira, Confluence, Databricks, Oracle DB𝙿̲𝚛̲𝚘̲𝚌̲𝚎̲𝚜̲𝚜̲ ̲𝚊̲𝚗̲𝚍̲ ̲𝙲̲𝚘̲𝚖̲𝚙̲𝚕̲𝚒̲𝚊̲𝚗̲𝚌̲𝚎̲:̲• CSV, GxP, SDLC (Agile & Waterfall)• Teamwork, adaptability, empathy, problem solving, active listeningo E2E: user stories, testing approach, project management, compliance deliverables, … go liveo Kanban, Jira-xRay, qTest, Asset management𝙿̲𝚛̲𝚘̲𝚍̲𝚞̲𝚌̲𝚝̲ ̲𝚖̲𝚊̲𝚗̲𝚊̲𝚐̲𝚎̲𝚖̲𝚎̲𝚗̲𝚝̲: Clinical Data Sciences and Analytics• HPT Product analyst and HPT Technical product ownero Projects and supporting GcP releaseso Within current project: Data mining AWS Databricks Spotfire GenAI

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  It Manager

  Johnson & Johnson

  Jan 1993 - Present

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  Industriele Hogeschool B.M.E Gent

  Information Technology