R&D Quality Manager (Medical Devices and/or Combination Products)

Job description

Job Description Summary -Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations. Job Description Major accountabilities: Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements -Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs -Aid in the identification of quality issues and assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed, completed and documented. Provide assistance in the remediation of deviations, Ensure follow up and monitoring of associated corrective and preventive actions. Manage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc. -Review and approve quality deliverables to ensure compliance (including procedures, records, third party work, contractors, clinical trial material, components, gap assessments ) Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Clusters Quality System in place and continuously updated, as required risks proactively identified and effectively mitigated -The number and severity issues identified during internal and external audits. Demonstrated/recognized leader of specific GxP; early external/industry engagement -Sufficient financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Sandoz culture, values and behaviors Minimum Requirements: Work Experience: Functional Breadth. Critical Negotiations. Project Management. Collaborating across boundaries. Skills: Agility. Analytical Development. Audit Management. Auditing. Business Partnering. Change Control. Continuous Learning. Health Authorities. Influencing Skills. Knowledge Of Capa. QA (Quality Assurance). Quality Management. Risk Management. Root Cause Analysis (Rca). Self Awareness. Six Sigma. Sop (Standard Operating Procedure). Technological Expertise. Languages : English. EEO Statement: Sandoz Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations Sandoz Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please connect with us outling the job requisition number in your message. Salary Range Skills Desired Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise