External Supplier Organization
2 weeks ago
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz
As the ESO Quality Assurance Manager you will be responsible for quality management at all worldwide 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 Sandoz quality manual, and relevant standard operating procedures (SOPs).
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 Sandoz 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 Sandoz 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 and Inclusion
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum Requirements
What you need for this 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 the Food and Drug Administration regulatory requirements concerning commercial products with proven record. The European Medicines Agency and other health authorities, important asset.
- Bilingual (English and French).
Why consider Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
The future is ours to shape
Sandoz
- Division
- SANDOZ
- Business Unit
- Quality STO
- 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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