Job Description

+250 molecules, including 20 of the 25 most important molecules on the market, Sandoz holds one of the most significant product portfolios in Canada. Sandoz is a Novartis Division.

As the ESO Quality Assurance Manager you will be responsible for quality management at external suppliers of biopharmaceuticals, pharmaceuticals and devices and for conformity of operational activities with current good manufacturing practices (cGMP), the Agreement relating to quality assurance, regulatory requirements, the Novartis Pharmaceuticals quality manual, and relevant standard operating procedures (SOPs).

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

• Act as a single point of contact/access point for all activities related to quality at the external supplier.
• Ensure that all aspects of handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products conform to the Novartis Pharmaceuticals quality manual, the Agreement relating to quality assurance, the regulatory requirements concerning cGMP and local SOPs.
• Manage significant quality problems (deviations, complaints, recalls, counterfeiting, product violations, stability problems, etc.) in accordance with the Agreement relating to quality assurance and the Novartis quality manual. Ensure that investigations are conducted properly.
• Assess trends in quality and ensure continuous improvement of processes and quality performance of products.
• Together with the head of supplier relationship management, provide guidance, develop strategies and make decisions to ensure the efficient operation of all external supplier activities; take part in investigations of external supplier cases.

Minimum requirements

Minimum requirements :
What you\'ll bring to the role:

• Bachelor\'s or higher degree in biochemistry, chemistry, microbiology or other science related to the area.
• 15 years of experience in the pharmaceutical industry, including direct experience with combination products / medical devices / pharmaceuticals / biopharmaceuticals / active ingredients.
• Experience in quality assurance, production, quality control and/or other relevant operational areas, including at least 3 years of experience in quality assurance, management and/or project management.
• Thorough knowledge of cGMP requirements.
• Excellent understanding of regulatory requirements concerning commercial products with proven record regarding the Food and Drug Administration, the European Medicines Agency and other health authorities.
• Fluency in English, both oral and written, French is an asset.

At Sandoz Canada, we care about our colleagues: we offer flexible work arrangements and competitive benefits. We\'d be happy to discuss this in our initial conversation.

Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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!

The future is ours to shape!

Functional Area

Quality

Division

SANDOZ

Business Unit

Quality STO

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are 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

Novartis