Global QMS Documentation Expert

Global QMS Documentation Expert

About the Role:

Ensure maintenance and continuous improvement of designated Quality processes and respective tools to drive standardization and harmonization further and meet compliance requirements. Lead/participate in key QMS projects or initiatives. Maintain knowledge with current industry trends, Health Authority expectations.

Key Responsibilities: 

• Act as a SME for selected Quality processes and collaborate with the respective QSO/Process owner to ensure GxP compliance of the processes and tools within own remit
• Contribute to an efficient end-to-end lifecycle of global GxP documents, focusing on initiation, drafting and review phases.
• Manage cross-functional assessment and endorsement of proposed changes in global GxP document landscape. Facilitate alignment among Authors, Quality system owners (QSOs), FR and Global QMS on the overall GxP Document Lifecycle process.
• Drive and facilitate an effective review process of Global GxP documents and engage with cross-functional community of Functional Representatives (FR). Support further simplification and harmonization of the review process across all GxP areas, including reviewer’s approval part in ESOPs.
• Act as Process Owner for designated processes to drive process lifecycle management from development to archiving of related IT systems.
• Author/review respective QMS documentation.
• Lead and/or participate in key QMS projects or initiatives ensuring that:
  • defined quality elements and compliance requirements are addressed,
  • all required activities for successful and timely execution are completed,
  • the roll-out to impacted local entities across Novartis is achieved.
• Establish and maintain community/network of Subject Matter Experts or Single Points of Contact and drive interactions with corresponding Functions.
• Establish strong partnership with key stakeholders.
• Create room to collaborate and opportunities by maximising lessons learned and communicating them to the SMEs and customers as applicable.
• Act as a QMS representative and liaison partner in other initiatives, boards, meetings as necessary.
• Participate in benchmarking activities as applicable and keep up to date with industry standards.
• Maintain knowledge of current industry trends and Health Authority expectations.

Essential Requirements:

• Minimum 8 years’ experience in Pharmaceutical, Chemical or Biological Operations
• Broad experience in QA processes and underlying regulatory requirements and industry standards/best practices
• Good understanding of principles of the Novartis Quality Management system and Quality Manual requirements in all regulated areas.
• Leadership and Project Management skills to ensure successful implementation of projects or initiatives
• Curiosity and agility to be able to adapt to fast moving environment
• Experience in working in a matrix environment.
• Being open to doing things in new/different ways
• Fast learner and Good communication skills

Desirable Requirements:

• University degree or equivalent experience in Pharmacy, Chemistry, Engineering or equivalent related discipline

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.