Quality Assurance Lead

hace 6 días

Madrid, España Roche A tiempo completo

.The Position Quality Assurance Lead Throughout our 125-year history, Roche has grown into one of the world's largest biotech companies and a global supplier of transformative innovative solutions across major disease areas. At Roche, we believe every employee makes a difference. We are passionate about transforming patients' lives. We are confident in both decision and action, we believe that good business means a better world. As a Quality Assurance Lead, you will be accountable for ensuring that Roche's regulatory and critical IT systems are reliable, compliant and meet acceptable risk standards. You will continuously evolve and improve Roche Informatics as an organization and be a trusted partner of innovations in Quality management. You will lead the IT Quality strategies, role model lean thinking, and strive for streamlined, simplified processes, leveraging on digitalized technologies, automation, AI, Cloud, data analytics, quality by design approach, and implementation of a risk-based approach. You will promote networked, agile ways of working, using creative leadership (Visionary, Architect, Catalyst and Coach) to unleash the potential of your team members and create an environment that fosters a great culture, a strong sense of belonging, personal growth, sharing and trust. Your key responsibilities : Leading a team of experts, providing independent oversight of delivery for regulatorily sensitive systems eg GxP, and ensuring the systems / products operate according to the defined policies and procedures. Defining and setting guardrails, SOPs, policies, and frameworks in close collaboration with Product Teams to enable fast decision-making and value realization. Guiding and monitoring the IT organization on adherence to the SOP and policies, ensure adoption, provide clear guidance and awareness on new regulatory mandates, and conduct periodic risk assessments. Fostering outside-in innovation, staying up to date with the external environment and trends. Understanding the business compliance drivers and ensuring there are smooth transitions between Quality Management systems of business. Aligning Quality & Compliance framework within 2nd line of control functions in Roche Informatics. Embedding compliance in the lean and agile processes, ensuring teams can focus on delivering compliant systems in an efficient way. Your qualifications and experience : You have around 5 years of demonstrated experience as a thought leader (in relevant field) with deep understanding of internal and external emerging GxP regulation, ITIL processes and associated disciplines. You are focused on the IT market, have a passion for researching major trends and leveraging those that would be advantageous for Roche. You have experience building high-performing teams, based on trust, collaboration, and career development for employees

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