Job Description

Together with our business partners, we ensure our patients can trust that our medicines are safe and compliant. As part of the Canadian Country Quality Team, you are responsible to support the operational activities for marketed products in Canada and ensure that all aspects of the operation comply with GxP, legal and regulatory requirements.

Your responsibilities:

• Ensure all quality-relevant processes within Country Organization are compliant and that non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues.
• Ensure quality oversight and governance to ensure proactive compliance with Company and Health Authority GxP requirements, and to meet business expectations.
• Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.
• Ensure the development of Quality Culture with high awareness on data integrity and close collaboration with business partners, and ensure 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, establish regular review and assessment of KQIs at the Executive Committees.
• Implement applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in the Organization.
• Ensure that relevant SOPs are aligned to HA regulatory requirements.
• Assist the Quality Assurance team with other GMP activities as required (i.e. recalls, audits, inspections, stability, APQR).

Minimum requirements

What you\'ll bring to the role:
Essential:

• 3- 5 years of experience within a Pharmaceutical , Biotech or equivalent business
• Demonstrated ability to work effectively in a multi-national, matrix organization
• Sound knowledge of Canadian GMP/GDP
• Experience associating with Health Canada through inspections or communications.
• Fluent in English and French
• Knowledge of Pharmaceutical operations regarding manufacturing process and regulations.
• Ability to communicate and write reports clearly.

Why consider Novartis?
236 million lives were touched by Novartis medicines in 2022. That\'s how many lives our products touch. 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!

Functional Area

Quality

Division

Operations

Business Unit

QUALITY

Employment Type

Temporary

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

Novartis