Zusammenfassung
About the Role
Major accountabilities:
Your responsibilities include, but are not limited to:
- Lead the development of a cross-divisional Quality Culture with high awareness on data integrity and close collaboration with business partners within Canada ensuring a state-of-the-art Country Quality Organization is in place to best support overall business strategy.
- Establish effective Quality oversight and ensure Quality Plan is implemented in Canada (HUBs & Operations, MS) namely for batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective Quality GxP areas.
- Lead the implementation of adequate Key Quality Indicators to monitor on an on-going basis that relevant processes are in control and compliant.
- Establish regular review and assessment of KQIs at the Country Level
- Lead the implementation of applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in Canada
- Ensure that relevant SOPs are aligned to HA regulatory requirements.
- Deliver successful GxP regulatory inspections and internal audits in the country.
- Continuously engage in benchmarking with other industries, industry peers and actively engage proactive relationships with Health Authorities
Lead the implementation and execution of the talent management strategy for all key positions in conjunction with other countries in the region.
What you’ll bring to the role:
Essential:
- Scientific or Technology Bachelor’s Degree (mini- mum), preferably in Chemistry, Pharmacy or Life Science. PhD desired
- At least 10 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development with a minimum of years of people management experience.
- Inspiring and developing Quality Organization in Canada, promoting agility, learning and growth.
- Strong leadership presence, with ability to effectively interact with and present to Senior Management, as well as to external audiences and health authority inspectors.
- Ability to influence key opinion leaders without hierarchical authority.
- Strong organizational awareness and business acumen (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.
- Business Partner and support the Product Lifecycle and product portfolio management, ensuring agility and readiness for advanced therapies launches.
- Fluency in English (oral and written), and French (oral and written), an additional language(s) a plus.
Desirable:
- Track record of successful cross- divisional/cross-functional work with complex international and multidisciplinary teams.
- Ability to influence and drive/facilitate change across the organization.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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