As the European Quality and Validation Manager, you will ensure that our Life Science projects provide a high level of quality that meets our customers’ expectations. You will support Life Science projects during the pursuit and throughout the project to ensure efficient execution in line with requirements and legislation. You will provide leadership to Validation Engineers working on European projects. To ensure project execution follows the planned methodology, you will perform Internal Quality Audits and report to the Director of Quality Europe. In This Role, Your Responsibilities Will Be To: Provide mentorship on current industry good validation practices, GxP regulations, and upcoming trends in Life Science compliance. Participate in the project pursuit phase to understand customer validation requirements, resolve appropriate project execution processes, and ensure validation costs are reflected in the bid. Allocate EU CSV resources to projects. Assist the project team in establishing accurate project planning activities. Take responsibility as Validation Lead for specific projects. Develop our QMS (PMO) and project execution tools in line with Life Science industry expectations, encouraging their use on projects. Support EU Quality Managers with External Audits from Life Science Customers. Perform Quality and Life Science training for relevant functions (Engineers, Project Managers, CSV team). Maintain the global CSV support team and mentor individual CSV engineers in Europe (indirect reports). Who You Are: You have a passion for being the ‘Quality Voice’, leading the organization successfully at both project and organizational levels. You can interpret customer validation requirements into an efficient validation strategy, breaking it down into vital activities and resources. You value structured approaches, can build and develop teams into experts, and possess strong networking, influencing, and communication skills. You are self-motivated. For This Role, You Will Need: Bachelor's degree or equivalent experience in Engineering or a Technical subject. Deep professional understanding of Quality and Computer System Validation within the Life Science sector. Strong interpersonal and leadership skills. Credibility and experience in engaging with customers and colleagues. Exceptional communication and presentation skills. Ability to foster a quality culture within the engineering Life Science team, ensuring each member understands their responsibilities and procedures. Willingness to travel for short assessments, workshops, and audits at customer sites. Preferred Qualifications that Set You Apart: • Technical understanding of Automation (S88), MES (S95), and industrial software. • Training and experience in ISO 9001 auditing. • Managerial experience in Operations and Quality. • Proficiency in English plus one additional European language. • Proven leadership, motivation, and team development skills. • An MBA is highly valued. • Membership in ISPE is a plus. Our Offer to You We prioritize work-life balance and support our employees' personal and professional growth. Our benefits include competitive plans, comprehensive medical care, and opportunities for advancement. Our flexible work-from-home policy allows you to optimize your work-life balance, combining remote days with collaborative office experiences. Additionally, our global volunteer employee resource groups enable connection with peers sharing similar interests, promote diversity and inclusion, and contribute positively to communities. J-18808-Ljbffr