347540BR
Jun 23, 2022
Canada

Job Description

160 is the number of Clinical Trials that are conducted under Novartis Canada oversight, with approximately 3,000 Patients and 1,000 Clinical Sites. In this role, you will propose, develop and implement strategies, processes, and lead oversight to ensure that the Novartis Pharmaceuticals Canada Inc. (Novartis Canada) and Sandoz Canada development, post-marketing surveillance activities and relevant GxP activities for Novartis Canada and Sandoz Canada comply with all applicable Canadian regulations, international regulations and internal standards. You will lead the implementation of the Novartis Quality Manual and Quality Management System for Novartis Canada’s Development and Post-Marketing Surveillance activities, to achieve a high level of quality and compliance. You can make a difference by joining our team.

Your Responsibilities:
Your responsibilities include, but not limited to:

• Provide leadership, strategic and business input impacting quality and compliance activities at Country Canada leadership team meetings/Quality Committee together with Canada NCQ Leader
• Lead a team of Quality professionals in the implementation and maintenance of the Novartis and Sandoz Canada Quality Management System governing development, post-marketing surveillance activities, and relevant Investigational Medicinal Product (IMP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) activities, ensuring compliance to applicable regulatory requirements and standards
• Ensure Key Quality Indicators are collected, monitored and reported. Ensure gaps are addressed to mitigate risk and facilitate continuous improvement.
• Responsible for compliance and oversight in the areas of Vendor Management, Training, Risk Identification/Management, Quality Issue and Incident Management, as they pertain to development and post-marketing surveillance activities.
• Lead/support the preparation, conduct and follow-up of development and post-marketing surveillance related Audits and local/foreign Health Authority Inspections at Novartis Canada, Sandoz Canada, external service providers and clinical trial sites.
• Lead complex investigation and novel projects (e.g. developing quality risk management strategies in novel situations) for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Degree in Life Sciences, Pharmacy or Medicines, or commensurate experience; advanced degree preferred and 7-10 years of Phase I-IV clinical trials and/or post-marketing surveillance experience.
• Expert knowledge of GCP/ICH regulations, Clinical Research and Pharmacovigilance requirements.
• Local and Foreign Health Authority inspection management experience.
• Strong Leadership Skills and Experience.
• Strong interpersonal, communication, negotiation and problem solving skills.
• Incumbent must be comfortable interacting with Key Opinion Leaders, Institutions, Health Authorities, etc. in both Official Languages: English and French.

You’ll receive:
An inspired, engaging and dynamic team of individuals to work with. Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme. Find out more about Novartis Canada: https://www.novartis.ca/

Why consider Novartis?
766 million. That’s how many lives our products touched in 2021. 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.

Imagine what you could do at Novartis!
Global Drug Development
QA GDD
Canada
Montreal
Quality
Full Time
Regular
No
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347540BR

Director, Development Quality Assurance

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