QA Operations Expert (d/f/m) / Ekspert upravljanja kakovosti - operacije (d/ž/m)

Job Description Summary

The future is ours to shape. / Prihodnost je v naših rokah.

Job Description

We are looking for a QA Operations Expert – Microbiology (d/f/m) to serve as the site Subject Matter Expert (SME) for microbiological and contamination control aspects of the new manufacturing and quality control facility for Bioinjectable products in Brnik.

This role is intended for an experienced quality professional who will play a key role in establishing, shaping, and continuously improving the site contamination control strategy, aseptic assurance programs, and microbiological quality systems. The successful candidate will provide expert leadership across multiple functions and act as the primary quality partner for microbiological and aseptic manufacturing topics.

By joining our company, you will have the opportunity to:

• •Shape the microbiological and contamination control strategy of a new state-of-the-art biologics manufacturing facility.
• •Act as a recognized site expert for aseptic manufacturing, contamination control, environmental monitoring, cleaning and disinfection programs.
• •Influence site-wide quality standards and operational excellence initiatives.
• •Collaborate with global experts and cross-functional teams to establish best-in-class aseptic manufacturing practices.
• •Lead strategic initiatives supporting facility start-up, process validation, technology transfers, regulatory inspections, and continuous improvement programs.
• •Mentor and develop colleagues, strengthening microbiological expertise across the organization.

Your responsibilities include, but are not limited to:

Within our multidisciplinary and highly innovative environment, you will independently lead and provide expert oversight for microbiological and contamination control activities, including:

• •Serve as the site SME for microbiology, contamination control, aseptic processing, environmental monitoring, cleanroom qualification, and operator qualification programs.
• •Define, establish, and continuously improve contamination control strategies in compliance with EU GMP Annex 1, FDA requirements, global regulations, and internal quality standards.
• •Lead the design, implementation, and lifecycle management of environmental monitoring, cleaning, disinfection, and microbial control programs.
• •Provide scientific leadership and risk-based decision-making for microbiological and aseptic process challenges, ensuring robust contamination control across manufacturing operations.
• •Review and approve investigations, root cause analyses, risk assessments, deviations, CAPAs, change controls, and validation activities related to microbiological and aseptic processes.
• •Provide expert oversight during facility design, commissioning, qualification, process validation, media fill programs, smoke studies, and technology transfer activities.
• •Monitor microbiological trends, contamination events, and quality risks, while leading regulatory inspections, audits, escalations, and corrective and preventive actions.
• •Collaborate with Manufacturing, MS&T, Validation, Engineering, Laboratory Operations, and Global Quality functions; develop standards, procedures, and training programs; and mentor colleagues to strengthen technical excellence and quality culture.

Essential Requirements

• •University degree in Microbiology, Biology, Biotechnology, Pharmacy, Chemistry, Chemical Engineering, Chemical Technology, or another relevant life-science discipline.
• •At least 4 years of significant professional experience in aseptic pharmaceutical manufacturing, microbiology, contamination control, quality assurance, or aseptic operations.
• •Demonstrated expertise in EU GMP Annex 1 and contamination control strategies for sterile manufacturing environments.
• •Experience leading complex investigations, risk assessments, validations, and cross-functional quality improvement initiatives.
• •Proven ability to influence decision-making across multiple functions and organizational levels.
• •Strong communication, stakeholder management, and leadership skills.
• •Fluency in English and Slovenian.

Preferred Requirements

• •Experience supporting regulatory inspections and customer audits.
• •Experience in biologics, biotechnology, or injectable manufacturing environments.
• •Previous involvement in facility start-up, commissioning, qualification, or technology transfer projects.
• •Knowledge of advanced contamination control concepts, rapid microbiological methods, and data-driven quality systems.
• •Experience mentoring, coaching, or serving as a technical subject matter expert.

What we offer:

• •Job location: Ljubljana and Brnik (Slovenia)
• •Contract type: permanent contract with 6-month probation period
• •Expected weekly working hours: 40
• •Pay range (annual gross salary): €45.120 - 67.680*

‘*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

• •Annual bonus (STI): percentage of annual salary
• •Vacation allowance : in 2026 it was €2,450.00 net
• •Christmas bonus : in 2025 it was €2,100 gross
• •OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG
• •Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary
• •Collective life and accident insurance (24/7 coverage)
• •A hybrid work environment offering flexibility and remote work possibilities – if applicable for position

• Ready for your next career move?
• You are kindly invited to submit your application in English and Slovene, including a CV, by October 16th, 2026.

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 the ambition to do more so that everyone can benefit from 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 a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

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 where diversity of thought is welcomed and where personal growth is supported!

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

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

#Sandoz

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Iščemo QA Operations Experta za mikrobiologijo (d/ž/m) , ki bo deloval kot ključni strokovnjak (SME) za področje mikrobiologije in kontrole kontaminacije v novem proizvodnem obratu ter laboratorijih za kontrolo kakovosti bioinjektabilnih izdelkov na Brniku.

Vloga je namenjena izkušenemu strokovnjaku za kakovost, ki bo imel pomembno vlogo pri vzpostavljanju, oblikovanju in nenehnem izboljševanju strategije kontrole kontaminacije, programov zagotavljanja aseptičnosti ter sistemov mikrobiološke kakovosti na lokaciji. Izbrani kandidat bo zagotavljal strokovno vodstvo na različnih področjih ter deloval kot ključni partner za vprašanja, povezana z mikrobiologijo in aseptično proizvodnjo.

S pridružitvijo našemu podjetju boste imeli priložnost:

Sooblikovati strategijo mikrob