ESO QA Manager

Posted 15 Days Ago
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Sandoz, CA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
The ESO QA Manager will oversee supplier quality, ensure compliance, support audits, manage deviations, and contribute to process improvements in pharma quality operations.
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Job Description Summary

Our ESO QA team is hiring!

Job Description

Are you passionate about ensuring high-quality standards in pharmaceutical products? Do you thrive in a dynamic, interdisciplinary, and international environment? If so, we invite you to join us at Sandoz, now operating with a renewed strategic focus, increased agility, and a strengthened culture.

Sandoz is a global leader in generic and biosimilar medicines. We are focused on agility, strategic clarity, and a strong culture to shape the future of affordable healthcare.

We are looking for a motivated and detail-oriented Quality Assurance Manager to support quality operations with external suppliers. This role focuses on ensuring compliance, supporting audits, and contributing to continuous improvement initiatives.

As ESO QA Manager, you will be responsible for the oversight of the supplier quality system compliance to mitigate risks related to product/API quality and to reduce costs associated to poor product quality, pursuant to the law, internal regulations, good practices and business objectives

Your key responsibilities will include:

  • Support External Supplier Qualification processes.

  • Act as SPOC for routine quality activities at external suppliers.

  • Assist in negotiating QAAs.

  • Manage changes, deviations, and complaints.

  • Escalate risks and support mitigation planning.

    Ensure timely delivery of project quality milestones.

  • Support in internal and external audits.

  • Review and approve Stability Reports and PQRs under supervision.

  • Contribute to QMS improvements and process simplification.

What you need to bring to the role:

  • University degree in Microbiology, Biotechnology, Biochemistry or equivalent.

  • Minimum 5 years of working experience in Pharmaceutical/Biopharmaceutical/API products. quality/quality assurance or operations.

  • Solid understanding of GMP-regulations (EMA; FDA, CA, etc). 

  • Strong communication and problem-solving skills.

  • Excellent skills in identifying issues and solving problems.

  • Fluent in English.

  • Audit Support

  • Communication Skills

  • Organizational Skills

  • Dealing with Ambiguity

  • Continuous Learning

  • Self-Awareness

  • Technological Expertise

  • Product Release

  • Goal Orientation

  

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!

The future is (y)ours to shape!

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Pioneering access for patients

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, visit Sandoz.com/careers

#ProudtobeSandoz

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Top Skills

Gmp Regulations
Quality Management Systems (Qms)
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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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