EMEA Regional Quality Integration Leader

Il y a 2 heures

Aalst, Flanders, Belgique BD Temps plein
pAs a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. /p pWe are the people who give possibilities purpose /p pBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. /p h3Job Description /h3 h3About the Role /h3 h3Main Responsibilities will include /h3 ul liDevelop and carry out regional quality integration strategies and plans that align with global quality objectives and local regulatory frameworks. /li liGuide cross-functional teams through the integration of quality management systems (QMS), processes, and procedures for newly acquired entities or major business changes within the EMEA region. /li liConduct gap analyses of existing quality systems against BD standards and applicable regulations (e.g., ISO 13485, MDR, IVDR), developing and implementing remediation plans. /li liHarmonization of quality documentation, training programs, and quality metrics coordinated across integrated sites. /li liAct as the primary point of contact for quality integration matters with regional business leaders, global quality teams, and regulatory affairs. /li liEnsure effective communication and change management strategies are in place to support successful quality integration. /li liMonitor and report on the progress of quality integration initiatives, identifying and mitigating potential risks. /li liParticipate in due diligence activities for potential acquisitions from a quality perspective. /li liProvide expert mentorship and support on quality integration challenges to regional teams. /li liFoster a culture of continuous improvement and quality excellence throughout the integration process. /li /ul h3About You /h3 ul liBachelor's degree or equivalent experience in a scientific, engineering, or related field. Master's degree preferred. /li liMinimum of 8-10 years of experience in Quality Assurance in the medical device or pharmaceutical industry. At least 3-5 years must be in a leadership or management role. /li liEstablished background in guiding and handling quality system integrations associated with mergers, acquisitions, or substantial organizational shifts. /li liComprehensive understanding of applicable medical device regulations (e.g., ISO 13485, EU MDR, IVDR, FDA QSR). /li liSolid knowledge of quality management concepts, tools, and approaches (e.g., CAPA, FMEA, lean manufacturing). /li liProven capability to guide and impact cross-functional teams within a complex, matrixed organization. /li liExcellent communication, interpersonal, and presentation skills with the ability to engage collaborators at all levels. /li liStrong analytical and problem-solving abilities. /li liFluency in English required; proficiency in other major European languages (e.g., German, French) is a significant advantage. /li liWillingness to travel regularly throughout the EMEA region (up to 40-50%). /li /ul pThis role is perfect for someone who thrives in a dynamic environment and is excited by the challenge of integrating quality systems across diverse regions and cultures. Join us and be a part of a team that is committed to clinical excellence and patient safety /p h3Why Join Us? /h3 pTo find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. /p pWe believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progres