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Regulatory Risk and Compliance Expert

hace 2 meses

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

As a Quality Compliance and Risk Manager at Novartis Farmacéutica, you will play a crucial role in supporting Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management processes and governance meet Novartis standards and Health Authorities' expectations.

You will engage with Research & Development (R&D) business, Quality Assurance (QA), and Enterprise Risk Management (ERM) risk teams to advocate a quality mindset and ensure Research & Development Quality (RDQ) risk management is executed with the highest quality.

Key Responsibilities:
  1. Support RDQ Risk Management: Manage risk documentation and governance structure, ensuring alignment with Novartis standards and Health Authorities' expectations.
  2. Provide Guidance and Expertise: Offer risk identification, root cause analysis, lifecycle management, and risk documentation support to QA and business partners.
  3. Proactively Identify Quality Risks: Ensure appropriate risk awareness and management, identifying potential quality risks to mitigate their impact.
  4. Enhance Governance and Processes: Support the enhancement of governance and processes for management of significant risks and issues in RDQ.
  5. Develop and Deliver Training: Create comprehensive training programs to ensure adherence to risk management standards and foster a culture of collaboration.
  6. Provide GxP Expertise: Offer guidance on process excellence across R&D/RDQ, ensuring compliance with GxP regulations.
  7. Participate in Cross-Functional Initiatives: Collaborate with cross-functional teams to drive risk management excellence and innovation.
Essential Requirements:
  1. Bachelor's Degree in Life Sciences or Business: A degree in Life Sciences or Business is required for this role.
  2. Excellent English Language Skills: Strong English language skills (oral and written) are essential for effective communication.
  3. Significant Relevant Work Experience: Significant relevant work experience in Quality Risk Management is required for this position.
  4. Strong Background in GXP and Health Authority Regulations: A strong background in GXP and relevant Health Authority regulations, paired with good business understanding, is necessary for success in this role.
  5. Ability to be Innovative: The ability to be innovative when faced with opportunities or challenges is essential for this position.
  6. Strong Continuous Improvement Mindset: A strong continuous improvement mindset and effective change management skills are required for this role.
  7. Excellence in Communication: Excellence in communication across different audiences and organizational levels is essential for success in this position.
  8. High Awareness of Trends: High awareness of trends and ability to proactively address needs based on external demands is necessary for this role.
Desirable Requirements:
  1. Experience in the Pharmaceutical Industry: Experience in the pharmaceutical industry or public health sector, in Drug Development, is desirable for this position.
  2. Experience Presenting to Senior Leaders: Experience presenting to and networking with senior leaders/stakeholders is highly desirable for this role.