Manager, Batch Release

2 weeks ago

Montréal, Canada Sandoz Full time

6,000 batches This is the number of batches that Sandoz distributes to Canadian patients every year. 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 ensure that Sandoz GMP activities conducted for marketed products, including services provided to our Private Label Partners are found compliant to all applicable Canadian regulations (and other applicable regulations, such as FDA) and Internal Standards.
- Your responsibilities include, but are not limited to:
- Oversees all aspects of the handling, release, and distribution of pharmaceutical products and ensure they are in compliance with registered specifications and GMPs, as well as internal policies and procedures.
- Manages all product quality issues (deviations, out-of-specification results, recalls, counterfeits, etc.) and ensure investigations are correctly executed to deliver on-time high-quality, compliant, safe, effective products to patients.
- Ensure robust performance management to optimize productivity.
- Provides technical support for new product launches, site transfers and product divestment.
- Leads the relationship with Private Label partners.
- Liaise with internal stakeholders and maintain KQIs / KPIs.
- Manages budget and ensure sound follow-up actions according to yearly budget plans.
- Lead and promote a strong Quality culture aligned with Sandoz quality values and processes.

**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._

**Minimum requirements**
- What you’ll bring to the role:
- Bachelor in sciences or equivalent and 5 -10 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.
- Ability to communicate and write reports clearly.
- Initiative, self-motivation and superior organizational and time management skills.
- Fluent in English and French is a must

You’ll receive:
- 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

**Division**
- SANDOZ

**Business Unit**
- COMMERCIAL OPS NA SZ

**Country**
- Canada

**Work Location**
- Montreal South Shore - Boucherville

**Company/Legal Entity**
- Sandoz Canada

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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