Commercial Quality Lead

Reposted 14 Days Ago
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Sandoz, CA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
As Quality Assurance Lead, you will implement governance and process oversight, develop Quality Culture, ensure compliance, and drive operational excellence projects.
Summary Generated by Built In

Job Description Summary

As the Commercial Quality Lead, you will drive the implementation of the Country Commercial Quality organization, ensuring governance and process oversight within the country under her responsibility.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
As the Commercial Quality Lead, you will drive the implementation of the Country Commercial Quality organization, ensuring governance and process oversight within the country under her responsibility.

Your responsibilities include, but not limited to:

  • Drive the development of Quality Culture with high awareness on data integrity and close collaboration with business partners and ensure Quality Operation is in place to best support overall business strategy within the country of her responsibilities.
  • Establish effective Quality oversight and ensure Quality Plan is implemented in the Country Organization (namely for commercial batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective risk assessment, effective Quality oversight for pharmacovigilance processes).
  • Drive the implementation of the Country Commercial Quality organization model within the country, with high focus on reducing Complexity and Simplification.
  • Actively support operational excellence projects in line with global process-streams and country quality strategy to meet local saving targets according to budget.
  • Ensure applicable Quality Standards and governance processes through the Sandoz Quality Manual implementation.
  • Establish effective Key Quality Indicators within the country to monitor on a routine basis the relevant processes, ensuring control and compliance.
  • Prevent any potential compliance gaps and risks and ensure CAPAs will be punctually addressed.
  • Support Implementation for adequate escalation process across the organization and effective timely resolution of any Quality Event.

Role Requirements:

  • Bachelor’s degree in pharmacy, registered pharmacist is a must.
  • Fluency in English and Vietnamese both oral and written, with the ability to negotiate effectively.
  • At least 8 years of Quality Assurance experience and involvement in regulated activities; broad understanding of global expectations of Health Authorities in the GMP, GDP, GCP, PV regulated areas. 3 or more years in a global/ matrix environment in the pharmaceutical industry experience.
  • Strong project management skills

Why 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.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!  

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.

#Sandoz

Skills Desired

Top Skills

GCP
Gdp
Gmp
Pv
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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​

​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​

We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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