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Novo Nordisk
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Head Clinical Operations Excellence

Head Clinical Operations Excellence

Novo Nordisk

3 - 15 years

0 Lacs

karnataka

Posted:2 days ago| Platform: Shine logo

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Skills Required

clinical quality compliance operational excellence regulatory compliance ema team handling performance management communication skills stakeholder management risk assessments trend analyses audit inspection readiness capa documentation stakeholder communication quality management reviews training plans operational strategies innovative solutions process improvements stakeholder satisfaction checks external regulatory authorities communication fda cdsco pmdo medical qualifications pharmacy qualifications life sciences qualifications digital tools systems

Work Mode

On-site

Job Type

Full Time

Job Description

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder communication, representing the CDC in regional and global clinical quality forums, ensuring compliance with local regulatory requirements, coordinating Quality Management Reviews (QMR), developing and executing yearly training plans aligned with operational strategies, driving innovative solutions for operational efficiency such as digital visit tracking and RBQM, identifying and implementing process improvements, conducting stakeholder satisfaction checks, measuring the effectiveness of new processes, and communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO. To be successful in this role, you should have 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality, 5 years of direct team handling experience with 360* performance management, completed qualifications in Medical, Pharmacy, Life Sciences, or another related field, a track record of driving innovation and process improvements in clinical operations, experience with digital tools and systems for operational excellence, excellent communication, and stakeholder management skills. The Clinical Development Centre (CDC) India is at the forefront of ensuring clinical quality and operational excellence. Based in a fast-paced and dynamic environment, the department proactively addresses clinical quality risks through risk assessments and trend analyses, ensures audit and inspection readiness, maintains compliance with local regulatory requirements, drives innovative solutions such as digital visit tracking and RBQM, represents CDC in global forums, and fosters collaboration with external regulatory authorities. With a culture of continuous improvement and a commitment to operational efficiency, the team thrives on delivering impactful results that make a difference. If you are interested in submitting your application, please upload your CV and motivational letter online. Internal candidates are kindly requested to inform their line Managers before applying. The deadline for applications is 01st Aug. 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. The company recognizes the importance of creating an inclusive culture that celebrates the diversity of employees, patients served, and communities operated in. Together, Novo Nordisk strives to be life changing.,

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Novo Nordisk

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Bagsværd Kalundborg

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Head Clinical Operations Excellence