Head of Clinical Quality Assurance

hace 4 semanas


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
About the Role

We are seeking a highly skilled and experienced professional to join our team as Head, Compliance Clinical QA. As a key member of our Development Team, you will be responsible for ensuring the quality and compliance of our clinical processes, aligning 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, 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. 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 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.


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    {"title": "Head Compliance CQA", "content": "About the RoleAs the Head of Clinical Quality Assurance, you will be responsible for ensuring the highest quality standards in clinical processes, ensuring compliance with Health Authorities requirements and internal standards.Key ResponsibilitiesDrive a culture of quality and embed a quality mindset across...


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    {"title": "Head Compliance CQA", "content": "About the RoleAs the Head of Clinical Quality Assurance, you will be responsible for ensuring the highest quality standards in clinical processes, ensuring compliance with Health Authorities requirements and internal standards.Key ResponsibilitiesDrive a culture of quality and embed a quality mindset across...


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    {"title": "Head Compliance CQA", "content": "About the RoleWe 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...


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    {"title": "Head Compliance CQA", "content": "About the RoleWe 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...


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    About the RoleThis is a key leadership position within our Innovative Medicines team, responsible for ensuring the highest standards of quality and compliance in our clinical processes. As the Head of Compliance Clinical Quality Assurance, you will be the primary quality contact for our Business Process Owners (BPOs) in Development, overseeing end-to-end...


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