Job Description

About The Role 2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz are you ready to make a difference Job Purpose: Execute Clinical QA oversight for Sandoz Development Centers Clinical Developments (CDs) of SSM and ensure steady state of quality and compliance for global clinical development activities according to GCP/GLP principles, cGMP requirements and as per applicable GxP guidelines, Health Authority regulations and Novartis/Sandoz standards. Your Key Responsibilities: Set up, implementation and maintenance of the SDCs Clinical Quality Management System, to ensure compliance with GCP/ GLP, local regulations, requirements, and Company standards. CQA support of Global Medical Development function located in Hyderabad. Support of SDCs Clinical Operations function on implementation and proper execution of GCP/ GLP quality related activities, including CQA support for clinical development activities. Lead/Participate in GCP audits and inspections in SDCs. Ensure SDC CDs GCP inspection and audit readiness. Escalate of high-risk GCP areas and issues (including inspection announcements). Plan and execute appropriate CQA review/assessments in SDCs, where applicable. Oversight of SSM GCP ESPs (external clinical providers) to ensure their proper qualification according international and Company GCP standards, including ESP qualification visits as and when required. Ensure the appropriate trainings and awareness of quality and compliance requirements and the SDCs Quality management System. Act as QARP or FURP in GX-QEM in the GCP audits of SDC CDs or ESPs. Support in preparation and follow up in implementation of appropriate corrective and preventive actions (CAPAs) from audits within SSM CDs. Ensure training matrices are created by CDs for their staff and trainings executed accordingly. Execute self-inspections of SDC CDs. Collaborate with other Product Development/SDCs departments involved in study activities. Collaborate with Global Clinical Quality Management (CQA) on Key Performance Indicators (KPIs), CQA initiatives and SSM CQA Team actions. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements At least 5 years\' experience in Clinical Operations or Clinical Quality Management Good knowledge of global regulatory framework, GCP experience, knowledge of EU and FDA and local regulations, ICH requirements and common quality standards Fundamental knowledge in pharmaceutical drug therapy (pharmacodynamics, pharmacokinetics) Experience in an international matrix organization Good intercultural communication and negotiation skills Strong analytical and organizational skills 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Sandoz! Division SANDOZ Business Unit Quality STO Work Location Hyderabad, AP Company/Legal Entity Sdz Pvt Ind Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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