This is a unique opportunity to lead the setup and operation of a new Quality Control (QC) laboratory at one of Europe’s largest biosimilar manufacturing investments. As QC Lead, you will play a central role in establishing lab infrastructure, building and mentoring a high-performing team, and ensuring QC systems meet global cGxP standards and regulatory expectations.
If you bring deep knowledge of biopharmaceutical quality control, proven leadership experience, and a strong foundation in GMP compliance, this role offers a chance to shape quality excellence from day one.
We offer:
- Employment at Slovenia’s most reputable employer
- Permanent contract
- Competitive salary and annual bonus
- Hybrid working model
- Relocation support if needed
- Pension scheme and employee recognition programs
- Health & well-being support via the “Energized for Life” initiative
- Unlimited access to learning and development opportunities
Main tasks:
- Lead the launch of a new QC laboratory for biosimilars testing, including purchasing and qualification of 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 that products meet specifications and requirements from the company, health authorities, and customers
- Leverage deep biosimilar and quality control knowledge to empower the 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
- Build and lead a high-performing team by recruiting, training, coaching, and developing talent, ensuring GMP qualification, compliance, and clear career paths within the organization
- Champion a safe and high-quality work environment by following HSE rules, promoting a safety culture, training others, identifying risks, and handling waste responsibly
- Ensure samples are tested and batches released on time
- Collaborate on GxP audits and inspections
We expect:
- 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
- Fluent in English (Slovenian is an asset)
