CMO Governance Manager

CMO Governance Manager

Job Description

Your responsibilities include, but are not limited to:

• To maintain and enhance Novartis standards, processes and tools for areas in scope of the Governance Office, such as phase IV studies, patient programs, managed access, and much more.
• Facilitate the correct implementation of these standards at country organizations and global functions across Novartis; provide central oversight at the Novartis CMO and Global Drug Development level.
• Support the development of training for associates and management to ensure adherence to standards; promote a culture of collaboration through delivery of education and learning opportunities, i.e. forums, summits, or regular meetings with customers.
• Identify quality and compliance risks for Novartis related to assigned areas and establish mechanisms to mitigate these risks. Actively contribute to maintain the ISO-9001 system and principles for assigned processes, products and services; participate in cross-functional projects to continuously improve Novartis standards, policies, guidelines, processes and systems to ensure better process adherence and to simplify the way we work.
• Support global inspection and audit preparation for quality and internal audits. To support the development, implementation and enhancement of the electronic systems, which the Governance Office owns.
• The two main components of that support will be the oversight on the system administration and management of the respective third party vendor; and the build of data science capabilities together with internal and potentially external partners.
• Promote change management and support a culture of quality, compliance and patient centricity; identify opportunities for global/local alignment. Maintain and enhance internal controls to measure compliance; review internal audit outcomes, perform country visits and support country self-assessments based on defined control matrices.
• Support country organizations to set-up and execute appropriate corrective and preventive actions plans in case of major audit or inspection findings. Demonstrate and act according to the Novartis values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization

Minimum requirements

• Master Degree in Science Doctor of Medicine (M.D.) or Pharm D. is a plus Excellent English language skills Relevant work experience (approx. 5 – 8 years) in the pharmaceutical industry or public health sector, in the area of medical, drug development, patient safety or compliance. Experience in vendor management is a plus.
• Basic knowledge in data science and the agility to learn about data analytics, data science and artificial intelligence is helpful. High learning agility, comfortable with complexity and diversity, and highly interested in continuous improvement.
• Very good communication skills across different audiences and organizational levels. Excellence in designing and continuously improving business processes to meet quality and compliance standards and to simplify the way we work.
• Ability to build strong and effective relationships with internal and external customers. Openness to change and ability to promote a culture of high ethical standards and compliance. External orientation and awareness of industry trends.

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Global Drug Development
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time