Site Quality Head (d/f/m) / Vodja kakovosti (d/ž/m)

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Job Description Summary The future is ours to shape. / Prihodnost je v naših rokah. Job Description The new Bio Injectable products manufacturing unit in Brnik will deliver advanced pharmaceutical products to patients worldwide, with a strong focus on biosimilars that require the highest standards of quality, professionalism, and dedication. If you are driven by purpose and want to co-create a success story with global impact through your expertise and commitment, we invite you to join us. As Site Quality Head (d/ž/m) , you will provide leadership and drive people development within the quality organization. You will be responsible for the development, implementation, and continuous improvement of quality assurance processes and quality control systems supporting release activities. In this role, you will ensure the delivery of high-quality, customer-focused services in compliance with applicable legislation, internal regulations, recognized good practices, and business objectives. Your key responsibilities: Quality Organization Leadership at Site Level: Leading, developing, and steering the quality function at the site, ensuring the professional and personal development of team members, as well as high levels of engagement and team performance. Product Quality Assurance and Oversight of Regulated Activities: End-to-end oversight of all activities impacting product quality, safety, and compliance across manufacturing, control, and distribution processes. Regulatory Compliance and Interaction with Health Authorities: Ensuring compliance with applicable legislation and internal requirements, maintaining product and site registrations, and preparing and maintaining core site documentation for regulatory purposes. Quality System Management and Risk Management: Conducting quality risk assessments, performing regular reviews of the Quality Management System, and ensuring effective handling of deviations, non-conformances, and complaints. Inspection Readiness, Audits, and Third-Party Management: Maintaining continuous readiness for regulatory and internal inspections and ensuring that collaboration with third parties is governed by appropriate quality agreements. Training and Competency of Employees: Ensuring employees are adequately trained and qualified to perform their tasks independently, with regular monitoring of training compliance and professional competencies. Safety, Health, Environment, and Business Continuity: Promoting a culture of safety and quality, ensuring compliance with health, safety, and environmental requirements, supporting crisis management activities, and ensuring business continuity. What you will bring to the role: University degree in Pharmacy, Chemistry, or another relevant scientific discipline. A minimum of 5 years of work experience in the field of quality, development, or manufacturing. Active proficiency in English. Proficiency in Microsoft Office tools.

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