Quality Compliance and Risk Management Specialist

hace 6 días

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, ensuring continuous improvement.
  5. Develop Comprehensive Systems: Develop and implement comprehensive systems and tools to support the RDQ risk management process, ensuring efficiency and effectiveness.
  6. Develop and Deliver Training: Develop and deliver training to ensure adherence to risk management standards, fostering a culture of collaboration and quality awareness.
  7. Provide GxP Expertise: Offer GxP expertise and guidance on process excellence across R&D/RDQ, ensuring alignment with regulatory requirements.
  8. Participate in Cross-Functional Initiatives: Participate in cross-functional initiatives to drive risk management excellence and innovation, contributing to the company's mission to reimagine medicine.
Essential Requirements:
  1. Bachelor's Degree: Hold a Bachelor's degree in Life Sciences or Business.
  2. Excellent English Language Skills: Possess excellent English language skills (oral and written).
  3. Significant Relevant Work Experience: Have significant relevant work experience in Quality Risk Management.
  4. Strong Background in GXP and Health Authority Regulations: Possess a strong background in GXP and relevant Health Authority regulations, paired with good business understanding.
  5. Ability to Innovate: Demonstrate the ability to be innovative when faced with opportunities or challenges.
  6. Strong Continuous Improvement Mindset: Possess a strong continuous improvement mindset and effective change management skills.
  7. Excellence in Communication: Demonstrate excellence in communication across different audiences and organizational levels.
  8. High Awareness of Trends: Possess high awareness of trends and the ability to proactively address needs based on external demands.
Desirable Requirements:
  1. Experience in the Pharmaceutical Industry: Have experience in the pharmaceutical industry or public health sector, in Drug Development.
  2. Experience Presenting to Senior Leaders: Possess experience presenting to and networking with senior leaders/stakeholders.

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