QC Lead – Biosimilars (d/f/m)

Posted 10 Days Ago
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Sandoz, CA
Senior level
Biotech • Pharmaceutical
The Role
The QC Lead will manage the Quality Control team for biosimilars at Sandoz, ensuring compliance with cGxP regulations, leading the launch of a new QC laboratory, and developing team talent. Responsibilities include equipment purchasing, method transfer, and collaboration with QA functions for global lab synergies while maintaining high-quality standards.
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Job Description Summary

The future is ours to shape.


 

Job Description

Sandoz | Lek made history in 2023: becoming independent and investing big in biosimilar production! Join us in Lendava and shape the future of biosimilars, innovation, and our impact on millions of lives. This is your chance to make a real difference!

We're seeking a QC Lead to manage and develop our Quality Control team. You'll ensure our quality control system runs smoothly, oversee the implementation of new testing methods, and keep everything cost-effective. You'll also share your expertise with the team and help them grow, making sure our quality standards are always top-notch.

Your key responsibilities: 

Your responsibilities include, but are not limited to:

  • You'll lead the launch of a new QC laboratory for Biosimilars testing, including purchasing and qualification laboratory equipment, transferring testing methods, building a quality control team, and setting up lab procedures.
  • Ensure that all activities comply with cGxP for data integrity and products meet specifications and requirements from our company, health authorities, and customers.
  • Leverage your deep biosimilar/quality control knowledge to empower your team with best practices (cGxP) while efficiently managing activities within budget and resources.
  • Ensure collaboration with different QA functions and quality teams across the company to develop lab talent and streamline global lab work to identify synergies.
  • You'll build and lead a high-performing team by recruiting, training, coaching, and developing talent, ensuring they're GMP-qualified, compliant, and on a clear career path within your organization.
  • You'll champion a safe and high-quality work environment by following HSE rules, promoting safety culture, training others, spotting risks, and handling waste responsibly.
  • You'll ensure samples are tested and batches released on time.
  • You’ll collaborate on GxP audits and inspections.

What you will bring to the role: 

  • University degree in pharmacy, chemistry or any other natural science degree.
  • Minimum of 8 years of working experience in the field of quality, development, and manufacturing in pharmaceutical or similar industries.
  • Excellent understanding of Quality Control in biopharmaceuticals.
  • Thorough understanding of GMP and other regulatory requirements (FDA would be an advantage).
  • Proven leadership skills and leading experience.
  • Excellent communication and interpersonal skills.
  • Strategic thinking and ability to develop a vision for the laboratory.
  • Ability to work in a team and lead projects.
  • Ability to adapt to changes in an international and fast-paced environment.
  • Ethics and integrity.
  • Active knowledge of English (written and spoken); proficiency in local (Slovenian) language is a plus.

You’ll receive:

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Relocation package, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. 

Possible job locations: Lendava (Slovenia)

We offer permanent employment with a 6-month probation period. 

You are kindly invited to submit your application in the English language, including your CV, by March 30, 2025.

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 ours to shape!

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

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: https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz #BioRampUp


 

Skills Desired

Top Skills

Biosimilars
Gmp
Quality Control
Regulatory Requirements
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The Company
HQ: Basel
110,000 Employees
Hybrid Workplace
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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