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Country Quality Head

3 months ago

Montreal Quebec GF, CA Novartis Full time
Summary

Location: Montreal, #LI-Hybrid. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the role: Ready to make a real difference in patients’ lives and their families? We are seeking a Commercial Quality Head to ensure safe and compliant products for our patients. In this role, you will listen to the voice of the customer and act as the contact for quality defects, counterfeits, and recalls, representing the face of Novartis to health authorities. Manage reputation and quality risks. This role will work directly with the Novartis Country Quality team and reports to the Novartis Country Quality Region LACan Head.

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, and effective Quality GxP areas.
  • Lead the implementation of adequate Key Quality Indicators to monitor on an ongoing 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 (minimum), preferably in Chemistry, Pharmacy, or Life Science. PhD desired.
  • At least 10 years of experience in the Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development with a minimum of years of people management experience.
  • Inspiring and developing a 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); 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?

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.

Division: Operations

Business Unit: Innovative Medicines

Location: Canada

Site: Montreal

Company / Legal Entity: CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

Functional Area: Quality

Job Type: Full time

Employment Type: Regular

Shift Work: No

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