Clinical Quality & Risk Manager

Job description

Clinical Quality & Risk Manager **Department name - Clinical Operations Excellence (COE)** **Organization - Novo Nordisk India Pvt Ltd (Affiliate)** **Location - Bangalore** Are you ready to shape the future of clinical trial quality at a company reaching more patients than ever beforeAs our new Clinical Quality Risk Manager, you will safeguard participant safety and data integrity across our clinical programmes turning risk insights into action and helping bring life-changing therapies to the people who need them. **Your new role** As Clinical Quality Risk Manager (CQRM), you will own the CQRM process/framework and be the strategic voice for its implementation and risk management within our Clinical Development Centre (CDC). You will identify emerging risks, design mitigation strategies, and champion a culture of continuous improvement ensuring every clinical trial we run meets the highest regulatory, ethical and scientific standards. **Day-to-day, your tasks will include:** - Performing ongoing quality risk assessments at country level, developing actionable mitigation plans, and acting as the point of contact for CDC management and Therapy Area units on risk management activities - Driving strategic quality planning to align clinical quality goals with organisational objectives, regulatory standards and internal policies, and leading the adoption of local process changes - Providing data-driven insights to CDC and global management using process analytics and digital tools conducting root cause analyses, supporting CAPAs and translating trends into local action - Leading cross-functional collaboration and change management, and representing Novo Nordisk at external forums to influence local regulations - Providing quality oversight throughout the lifecycle of clinical programmes, including supporting GCP site visits, CDC audits, Sponsor and site inspections, and the resolution of serious or data breaches - Serving as the local point of contact for Health Authority inspections and acting as a clinical quality advocate to institutional and country boards - Coordinating local training release with SMEs, championing centralised training solutions and monitoring training compliance and effectiveness In Clinical Operations Excellence you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. You will join Clinical Operations Excellence (COE) within the CDC the team that sets the standard for how clinical trials are designed, executed and continuously improved. We work shoulder-to-shoulder with trial squads, Global Project Teams, central monitoring and clinical operations leadership, ensuring that quality and risk thinking is embedded into every stage of clinical development. Your contribution will directly strengthen how we protect trial participants and deliver reliable data to advance our pipeline. **Your skills qualifications** - A Bachelor's degree in Life Sciences, Pharmacy or a related field (Master's preferred), combined with 5+ years of relevant experience in clinical operations or a quality role within the pharmaceutical industry or a CRO - Proven experience in quality management/assurance with a focus on risk-based quality and quality-by-design, including proficiency in electronic QMS platforms and a strong command of GCP and clinical development - A solid understanding of data integrity principles, emerging clinical trial technologies, global regulations, and demonstrated expertise in regulatory submission and inspection management - Demonstrated ability to ensure high-quality execution of clinical trial activities in line with ICH-GCP, regulatory requirements and internal SOPs, supported by strong project management, planning and prioritisation skills - Excellent interpersonal, negotiation, and problem-solving skills, with the ability to present and communicate with clarity and impact to senior internal stakeholders and external inspectors alike - Fluency in English, both written and spoken **Disclaimer** It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organisations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment, or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.