Head of Clinical Quality Assurance
hace 4 semanas
About the Role
We are seeking a highly skilled Head of Clinical Quality Assurance to join our team at Innovative Medicines. As a key member of our Development Team, you will be responsible for ensuring the quality of our clinical processes and ensuring compliance with Health Authorities requirements and internal standards.
The ideal candidate will have a deep understanding of global expectations of Health Authorities in the area of Clinical Development and a profound understanding of the science of product development. They will also have a strong background in regulated activities (GCP/PH), clinical development, and/or QA position in the pharmaceutical drug development.
Key Responsibilities
- Actively drive a culture of quality and successfully embed a quality mindset across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
- Guide Quality System Owners (QSOs) and Business Process Owners (BPOs) in the development of a robust strategy for clinical process changes, considering interdependencies and guiding respective risk business owners in all aspects of risk management.
- Collaborate closely with BPOs to prepare for audits, actively participate, support formulating a robust CAPA plan, ensuring its comprehensive review and flawless implementation.
- Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Manager(s) when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process.
- 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. Drive continuous improvement through data-generated insights for the respective clinical processes, fostering a culture of excellence.
Requirements
- Master's degree in life sciences / healthcare, M.D, Ph.D, or MBA.
- At least 10 years of involvement in regulated activities (GCP/PH), clinical development, and/or QA position in the pharmaceutical drug development.
About Us
Innovative Medicines is a leading pharmaceutical company that is committed to reimagining medicine to improve and extend people's lives. We are optimizing and strengthening our processes and ways of working to bring our medicines to patients even faster.
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