External Supplier Organization

3 weeks ago

Montréal, Canada Novartis Argentina Full time

Job ID- 365203BR- Mar 09, 2023- Canada**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.

**Diversity & Inclusion / EEO**:

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

**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.
- 10 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.

You’ll receive:
- Why consider Sandoz?
- Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we
- continue to pioneer access in an ever-more digital and global world?
- The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
- Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
- Imagine what you could do at Sandoz

Division
- Novartis Technical Operations

Business Unit
- NTO SANDOZ TECHOPS

Location
- Canada

Site
- Montreal South Shore - Boucherville

Company / Legal Entity
- Sandoz Canada

Functional Area
- Quality

Job Type
- Full Time

Employment Type
- Regular

Shift Work
- No

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