Novartis

Job ID

368722BR

Job Description

#1! This is the position Sandoz Canada will achieve in the Bio-Generic market by 2025. At Sandoz, our purpose is to pioneer access for patients. Our business ambition is to be the world’s leading and most valued generics company.

In this role, you will be responsible to lead all operational aspects of the business to ensure compliance within a complex local regulatory framework, regional and international relevant GxP regulations, as well as legal and compliance requirements, and the Sandoz Quality Manual and Policies.

#1! This is the position Sandoz Canada will achieve in the Bio-Generic market by 2025. At Sandoz, our purpose is to pioneer access for patients. Our business ambition is to be the world’s leading and most valued generics company.

In this role, you will be responsible to lead all operational aspects of the business to ensure compliance within a complex local regulatory framework, regional and international relevant GxP regulations, as well as legal and compliance requirements, and the Sandoz Quality Manual and Policies.

#1! This is the position Sandoz Canada will achieve in the Bio-Generic market by 2025. At Sandoz, our purpose is to pioneer access for patients. Our business ambition is to be the world’s leading and most valued generics company. In this role, you are responsible to lead all operational aspects of the business to ensure compliance within a complex local regulatory framework, regional and international relevant GxP regulations, as well as legal and compliance requirements, and the Sandoz Quality Manual and Policies.

Your responsibilities include, but are not limited to:

• Ensure proactive compliance with Company and Health Authority GxP requirements, as well as business expectations.
• Leads and manages all product complaints, including investigations, to deliver on-time high-quality, compliant, safe, effective products to patients.
• Lead all change control process activities and ensure appropriate documentation. Liaise with all external stakeholders and ensure alignment with Regulatory Affairs.
• Ensure appropriate alignment of all internal processes and procedures with local regulatory requirements.
• Manages on target budget of all relevant QA supporting activities, and ensure sound follow-up actions according to yearly budget plans.
• Ensure robust performance management to optimize productivity across the organization.
• Act as primary point of contact with external stake holders for all QA relevant supporting activities for Sandoz Canada.
• Lead and promote a strong Quality culture aligned with Sandoz quality values and processes.

Position Title

Manager, Quality Operations

Minimum requirements

What you’ll bring to the role:

• Bachelor in sciences or equivalent and 10-12 years of experience in Pharmaceutical, Biotech or equivalent
• Demonstrated ability to work effectively in a multi-national, matrix organization
• Extensive knowledge of Canadian GxPs as well as FDA and other international regulations.
• Promote continuous improvement and creative thinking
• Initiative, self-motivation and superior organizational and time management skills.
• Fluent in English and French is a must

You’ll receive:

Competitive salary, sales incentive, pension scheme, health insurance, flexible working arrangements, employee recognition scheme. Find out more about Sandoz Canada: https://www.sandoz.ca/

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz

Job Type

Full Time

Country

Canada

Work Location

Montreal South Shore – Boucherville

Functional Area

Quality

Division

SANDOZ

Business Unit

COMMERCIAL OPS NA SZ

Employment Type

Regular

Company/Legal Entity

Sandoz Canada

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

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