Compliance Clinical Quality Assurance Head

hace 3 semanas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
About the Role

As the Head of Compliance Clinical Quality Assurance, you will be responsible for overseeing the quality of clinical processes within our Development Team. This involves ensuring compliance with Health Authorities' requirements and internal standards.

Key Responsibilities
  1. Drive Quality Culture: Foster a culture of quality and excellence across Development by building strong partnerships with Business Process Owners and implementing effective quality strategies.
  2. Develop Clinical Process Strategies: Collaborate with Quality System Owners and Business Process Owners to develop robust strategies for clinical process changes, considering interdependencies and risk management.
  3. Prepare for Audits: Work closely with Business Process Owners to prepare for audits, actively participate, and support the development of a comprehensive CAPA plan.
  4. Collaborate with Inspection Teams: Collaborate with the Head GCP Inspection Management and GCP Inspection Project Manager(s) to identify potential risk areas during GCP Health Authority Inspections.
  5. Support Presentations and Deliverables: Guide Business Process Owners in preparing for presentations and deliverables requested during inspections.
  6. Proactively Address Gaps and Risks: Identify potential gaps and risks, and drive continuous improvement through data-generated insights for clinical processes.
Your Experience
  1. Master's Degree or Higher: A Master's degree in life sciences, healthcare, or a related field is desired.
  2. Regulated Activities Experience: At least 10 years of experience in regulated activities (GCP/PH), clinical development, and/or QA positions in pharmaceutical drug development.
  3. Global Health Authorities Expectations: A broad understanding of global expectations of Health Authorities in Clinical Development and a profound understanding of product development science.
  4. Collaboration and Communication: High learning agility, mentally quick, comfortable with complexity and diversity, and highly interested in continuous improvement.
  5. Stakeholder Engagement: Effectively collaborate with stakeholders at all levels of the organization, inspiring and motivating cross-functional teams to drive change and promote a culture of excellence.
  6. Communication Skills: Ability to present to senior management, corporate functions, and external audiences, including health authorities and government officials.
  7. Language Skills: Proficient English language skills.


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