Qualified Person (d/f/m)

Reposted Yesterday
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Sandoz, CA, USA
In-Office
78K-78K Annually
Senior level
Biotech • Pharmaceutical
The Role
Responsible for site-wide quality operations as the certified Qualified Person, ensuring GMP-compliant, on-time release of internal and external (large-molecule) products. Oversee quality systems (deviations, CAPAs, complaints, OOS/OOE), support audits and regulatory interactions, collaborate with Production, QC and Regulatory, and drive continuous improvement and operational excellence.
Summary Generated by Built In

Job Description Summary

Qualified Person (d/f/m) – Quality Operations | Kundl, Austria

Job Description

We are seeking an experienced and highly motivated Qualified Person (QP) to oversee and ensure the highest standards of Quality Operations across our site. This role is critical in ensuring compliance with regulatory requirements and maintaining product quality across both internally manufactured and externally supplied products (large molecules).

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Quality Operations oversight across the site
  • Perform market and technical release of external products
  • Ensure GMP-compliant, on-time product release
  • Drive quality systems excellence (deviations, CAPAs, complaints, OOS/OOE)
  • Support inspections, audits, and regulatory interactions
  • Collaborate cross-functionally with Production, QC, Regulatory & more
  • Contribute to continuous improvement and operational excellence initiatives

What you’ll bring to the role:

Essential Requirements:

  • Certified Qualified Person (QP)
  • Master’s degree in pharmacy, Chemistry, Biology, or similar
  • 5+ years in pharma/biotech QA/QC
  • Strong knowledge of GMP, product release, and quality systems
  • Experience in cross-functional collaboration and leadership
  • Fluent in English & German

You´ll receive:

  • Attractive salary with incentive program
  • Modern company pension scheme
  • Flexible working hours / home-office depending on the position
  • 14 weeks of paid parental leave
  • Additional days off (bridge-days)
  • Subsidized meals in our canteen
  • Sustainable mobility in form of company transportation and shift buses
  • Company Kindergarden and summer camps for children
  • Wellbeing & mental health offers
  • Learning and development options for your personal and professional growth
  • Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 78.383,90 /year (on a full-time basis).

The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum 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 careers, where diversity of thought is welcomed and where personal growth is supported! 

Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.

If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at [email protected].

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, join the Network here: Sandoz Talent Pool

#Sandoz

Skills Desired

Skills Required

  • Certified Qualified Person (QP)
  • Master's degree in Pharmacy, Chemistry, Biology, or similar
  • 5+ years in pharma/biotech QA/QC
  • Strong knowledge of GMP, product release, and quality systems
  • Experience in cross-functional collaboration and leadership
  • Fluent in English and German

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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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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