Summary
Head, Compliance Clinical Quality Assurance. Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today – we will thrive together!
About the Role
Job Purpose:
Are you ready to become the Head, Compliance Clinical QA? As primary quality contact for Business Process Owners (BPOs) in Development, you will be responsible for end-to-end quality oversight of clinical processes, ensuring compliance with Health Authorities requirements and internal standards. The individual will be a deep thinker and data focused, extracting information from different data sources and summarizing it in a way that is actionable.
Key requirements:
Actively drive a culture of quality and successfully embed a quality mindset across Development by forging strong business partnerships.
Guide Quality System Owners (QSOs) and BPOs in the development of a robust strategy for clinical process changes.
Collaborate closely with BPOs to prepare for audits, actively participate, and support formulating robust CAPA plans.
Collaborate with the Head GCP Inspection Management and GCP Inspection Project Manager(s) during GCP Health Authority Inspections.
Guide BPOs in preparing for specific presentations and deliverables requested during inspections.
Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement.
Your Experience:
Master's degree in life sciences / healthcare, M.D, Ph.D or MBA is desired.
At least 10 years of involvement in regulated activities (GCP/PH), clinical development and/or QA position in the pharmaceutical drug development.
Broad understanding of global expectations of Health Authorities in Clinical Development.
High learning agility and interest in continuous improvement.
Effectively collaborating with stakeholders at all levels of the organization.
Ability to present to Novartis senior management and external audiences.
Proficient English language skills.
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.
Location:
Spain, Barcelona Gran Vía
Job Type:
Full time, Regular
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