Country Study Manager / Local Quality Responsible

Country Study Manager / Local Quality Responsible page is loaded## Country Study Manager / Local Quality Responsiblelocations : Oslotime type : Full timeposted on : Posted Todaytime left to apply : End Date : September 27, 2025 (7 days left to apply)job requisition id : At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.### ### The PositionYou are a strategic and process-oriented professional with subject matter expertise in Good Clinical Practice (GCP) with a passion for both evidence generation and quality management. This position offers the opportunity to be a key player in ensuring our evidence generation projects such as RWE and clinical trials are executed according to international standards and maintaining the high standards of our Quality Management System (QMS).

• The Opportunity
• As a Country Study Manager (CSM), you will :
• Plan and implement clinical studies and / or other evidence generation projects such as real world data projects :
• Have overall operational responsibility for the planning, initiation, and implementation of clinical studies or evidence generation projects in Norway, ensuring they align with internal and external procedures as well as the overall disease area strategies.
• Provide expertise in evidence generation projects including clinical trials :
• Act as a resource person for internal colleagues and contribute to cross-functional teams related to clinical studies or evidence generation
• Ensure Compliance :
• Oversee and manage evidence generation projects in compliance with applicable regulations, protocols, and timelines.
• Collaborate in cross-functional teams and cross- country networks :
• Ensure effective collaboration with international and cross-country networks, contributing to global study initiatives.As a Local Quality Responsible (LQR), you will :
• Implement and Lead the QMS :
• Drive the implementation of the global Roche QMS at the affiliate level, ensuring compliance with all local and international regulatory requirements.
• Lead and maintain affiliate
• SOP management system
• within GCP and GVP.
• Manage Medical Compliance :
• Oversee and lead the affiliate's medical compliance processes, including risk management and quality monitoring strategies.
• Provide Quality Oversight :
• Lead and act as a trusted quality partner, supporting audits and inspections, and proactively identifying and mitigating risks.
• Champion Quality Culture :
• Promote and advocate for an enterprise-wide quality culture by acting as a Visionary, Architect, Coach, and Catalyst (VACC).
• Service provider oversight :
• Oversight of service providers within GCP and PV.
• Who You Are
• You thrive in a dynamic collaborative environment which is highly regulated. In this role, you are able to transition between strategic oversight and operational hands-on execution.
• Education
• : A university degree in a medical or science-related field is preferred. Master in Pharmacy or equivalent.
• Experience
• : + The preference is at least 5 years of professional experience in the biopharmaceutical industry. + Experience in audits and health authority inspections is highly desirable. + Demonstrated expertise in both QMS and clinical trial management is a strength. + Experience with real world evidence is a strength, either locally or regionally. + Applied and documented knowledge of ICH GCP, GVP, and other relevant regulations. + Knowledge or experience with medical devices is a plus but not a requirement.
• Skills
• : + Exceptional partnering and networking capabilities. + Strong quality mindset, with the ability to influence and lead without direct authority. + Risk based and pragmatic mindset with the ability to focus where it matters and simplify in highly regulated environments + Excellent verbal and written communication skills in both English and Norwegian. + Highly self-motivated and able to lead initiatives with a focus on outcome-based planning.# Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.
• Roche is an Equal Opportunity Employer.

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