Head of Clinical Quality Assurance
hace 2 semanas
About the Role
We are seeking a highly skilled and experienced professional to join our team as Head of Clinical Quality Assurance. As a key member of our Development Team, you will be responsible for ensuring the highest quality standards in clinical processes, ensuring compliance with Health Authorities requirements and internal standards.
Key Responsibilities:
- Drive a culture of quality and embed a quality mindset across Development by forging strong business partnerships and implementing the strategy, mission, and purpose of RDQ.
- Guide Quality System Owners and Business Process Owners 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 Business Process Owners to prepare for audits, actively participate, and 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 Business Process Owners in preparing for specific presentations and deliverables requested during inspections.
- Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement, driving continuous improvement through data-generated insights for the respective clinical processes, fostering a culture of excellence.
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 the area of Clinical Development and profound understanding of the science of product development.
- High learning agility, mentally quick, comfortable with complexity and diversity, and highly interested in continuous improvement.
- Effectively collaborating with stakeholders at all levels of the organization with a possibility to inspire and motivate cross-functional teams to drive change and promote a culture of excellence.
- Ability to present to Novartis senior management, corporate functions, and to local executive team members, as well as to external audiences, health authorities, and government officials.
- Proficient English language skills.
Why Novartis:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Commitment to Diversity & Inclusion:
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