Global QMS Manager

Global QMS Manager

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
• Act as Process Owner for designated processes to drive process lifecycle manage-ment from development to archiving of related IT systems.
• Author/review respective QMS documentation.
• Oversee Quality System Landscape and facilitate changes needed to ensure adapta-tion of Novartis QMS to meet the changing business and patient needs
• Support the network of QSOs, facilitate QSO to QSO interactions, provide tools and templates to ensure standardized execution of key activities
• 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 customers.
• Create room to collaborate and opportunities by demonstrating lessons learned and communi-cating 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 indus-try standards.
• Maintain knowledge of current industry trends and Health Authority expectations.

Essential Requirements:

• Min. 8-10 years’ experience in the pharmaceutical industry in a relevant field, such as acting as Qualified person, quality assurance, quality control, registration, clinical development or manufacturing or a directly related area.
• Broad experience in QA processes and underlying reg-ulatory requirements and industry standards/best practices
• Good understanding of Novartis QMS principles
• 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
• Being open to doing things in new/different ways
• Fast learner, good communication skills, interpersonal, communication, negotiation and problem-solving skills. Experience in working in a matrix environment.
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams

Desirable Requirements:

• University degree or equivalent experience in Pharmacy, Chemistry, Engineering or equivalent related field
• Knowledge and experience in general QA and compliance activities

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.