Inactive
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Sandoz

Leader in generic and biosimilar medicines

Quality Team Lead QC Microbiology

Regulatory & Quality (Life Sciences)Posted on Oct 14
Full-timeLendava, Slovenia€65.8k - €98.8k /yr

About the Job

Requirements

  • A university degree in microbiology, pharmacy, biotechnology, or a related field.
  • Experience in microbiology within the pharmaceutical industry and strong knowledge of cGxP and Good Laboratory Practices.
  • Significant leadership experience, ideally 6–10 years, with a proven track record of developing talent, building engaged teams, and driving performance.
  • A strong understanding of regulatory requirements, including EU and FDA requirements, and experience with audits and inspections.
  • Strong analytical skills, a proactive mindset, and a problem-solving orientation.
  • Very good written and spoken English.

Responsibilities

  • Strategically lead and develop the Microbiology Laboratory to ensure seamless operations and full compliance with cGxP requirements.
  • Oversee and coordinate microbiological testing of raw materials, intermediates (IPC), active pharmaceutical ingredients, and environmental samples in line with safety, quality, and regulatory standards.
  • Ensure compliance with Good Laboratory Practices and align activities with national legislation, EU guidelines, FDA requirements, and other relevant regulatory authorities; actively support internal and external audits and inspections.
  • Lead investigations of deviations, OOX results, and complaints, and collaborate on designing and implementing corrective and preventive actions (CAPA).
  • Promote continuous improvement and operational excellence within the microbiology department.
  • Manage training programs and foster team members’ professional development in line with cGxP requirements; monitor performance and ensure competency.
  • Provide scientific support to microbiological quality control, manufacturing, and regulatory affairs, including preparing and submitting documentation.
  • Coordinate departmental operations and provide expert microbiological support for production processes and regulatory compliance.

About the Company

Sandoz

Leader in generic and biosimilar medicines

What does the company do? Sandoz is a global leader in generic and biosimilar medicines, with a broad portfolio of about 1,300 products that address diseases from the common cold to cancer. How does its product work? The medicines are off-patent (generics) or biosimilars that match the reference brands in safety, quality, and efficacy, offering affordable treatment options to patients and helping healthcare systems save money while expanding access. How is it different from competitors? Sandoz emphasizes scale, a long heritage dating back to 1886, and a sizeable global workforce dedicated to broadening patient access, aiming for large social impact and substantial healthcare savings. Its leadership in biosimilars and the breadth of its portfolio set it apart in the market. What is the company's goal? To pioneer access for patients by making high-quality medicines more affordable and widely available worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1886

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