Aktuelle Jobs im Zusammenhang mit Head Clinical Development Quality Biosimilar - Munich - Novartis
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Director Clinical Development
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Clinical Services Engagement Associate
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Clinical Services Engagement Associate
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Head Clinical Development Quality Biosimilar
vor 4 Monaten
2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role
**Are you ready to make a difference?**
**Role Purpose**
Leads Sandoz Biosimilar Clinical QA team and provides Quality oversight across SDZ Bio-pharma clinical development programs (internal and external), as well as on the Biosimilar Clinical Trial Process and respective Clinical Quality Systems, in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to the principles of patients’ safety, rights and well-being as well as data integrity.
**Your Key Responsibilities**:
- Proactively provides QA inputs for the clinical development business strategy and clinical Quality Systems for Biosimilar clinical development projects in cross-functional collabora-tion.
- Accountable for the implementation of the agreed (clinical) quality strategy within Bio-pharma Clinical QA team and Biopharma Clinical Development (BCD).
- Aligns activities, initiatives, and reporting in Biopharma CQA team.
- Proactively support and collaborate with key stakeholders to ensure that quality risks are detected, remediated, and escalated when needed.
- Ensures oversight of execution of Clinical Trial Quality Risk Management process (CT-QRM) in Biopharma Clinical Development including submissions.
- Ensures inspection readiness activities are in place and incorporated in clinical develop-ment processes.
- Actively leverages audit/inspection outcomes/trends to feed into improvement in clinical trials conduct.
- Provides robust and clear quality oversight in the following areas of clinical development.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- At least 5 years experience in Clinical Operations or Clinical Quality Management
- Good knowledge of global regulatory framework, GCP experience, knowledge
- Good knowledge of EU and FDA 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 organisational skills
- Entrepreneurial, dedicated, inspiring, process and performance-oriented personality with innovative and critical thinking
Orbit
**Why Sandoz?**
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**
Sandoz Global Development
**Country**
Germany
**Work Location**
Holzkirchen (near Munich)
**Company/Legal Entity**
Sandoz International
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
