Quality Specialist - Responsible Person (Maternity Cover) (Maternity Cover)
Location: Harbor Park Logisztikai Központ, Campona Utca
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.
At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Nospa, Magne, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission to bring health in your hands at www.opella.com.
As the Country Quality Manager & Responsible Person for Hungary, you will play a crucial role in ensuring that Opella’s products meet the highest quality and regulatory standards. You will oversee the local Quality Management System, support GxP‑regulated activities, and act as the primary contact for health authorities when needed.
This is a key position for someone who thrives in a highly regulated environment, enjoys cross‑functional collaboration, and wants to contribute to the safety, quality, and integrity of Opella’s Consumer Healthcare products in Hungary.
Support and continuously strengthen the Country Quality Management System
- Ensure that all quality processes in Hungary are fully aligned with CHC global standards, local GxP/GDP regulations, and Opella’s commitment to product integrity.
- Oversee the lifecycle of controlled documents, SOPs, and quality procedures, ensuring they are accurate, up‑to‑date, and effectively implemented.
- Support the training strategy for all GxP‑related functions, ensuring colleagues understand requirements and apply them in their daily work.
Act as Responsible Person back‑up and safeguard regulatory compliance
- Serve as a key contact for Competent Authorities on quality, GMP/GDP, and product‑related matters when deputizing for the Responsible Person.
- Ensure quality oversight of wholesale distribution activities, including storage, handling, and delivery of medicinal products distributed in Hungary.
- Maintain readiness for inspections and audits by ensuring processes are robust, documented, and consistently executed.
Ensure high standards in quality operations and issue management
- Oversee the full management of quality events, deviations, and CAPAs, ensuring timely documentation, escalation, and resolution.
- Ensure proper execution of Product Technical Complaints (PTC) investigations, working closely with global and local stakeholders.
- Coordinate recall activities when required, ensuring rapid and compliant execution across internal teams and external partners.
Promote quality excellence across the affiliate and partners
- Collaborate with Regulatory Affairs, Medical, Pharmacovigilance, Supply Chain, and Commercial teams to ensure quality is embedded across all CHC activities.
- Support qualification and periodic review of suppliers, distributors, and service providers to ensure they meet GxP and GDP standards.
- Monitor storage and distribution conditions to ensure products remain compliant throughout their lifecycle.
Leverage data, insights, and risk management to drive improvement
- Identify risks proactively using quality risk management tools, ensuring mitigation actions are defined, implemented, and monitored.
- Analyze trends from quality events, complaints, audits, and operational data to improve processes and prevent re‑occurrence.
- Contribute to local and global quality improvement initiatives, bringing forward ideas that simplify processes, improve compliance, and enhance operational efficiency.
Ensure inspection readiness and support successful audits
- Prepare for and participate in internal audits, corporate audits, and Health Authority inspections.
- Ensure findings are addressed promptly, corrective actions are implemented, and long‑term improvements are sustained.
Champion a culture of strong ethics, compliance, and operational excellence
- Act as a role model in upholding Opella’s ethical and compliance standards.
- Promote continuous learning, high-quality decision‑making, and cross‑functional collaboration to ensure the affiliate delivers safe, compliant, and reliable products to patients and consumers.
- 1 year of relevant experience in a wholesale distribution environment. Being able to be nominated as Responsible Person in accordance with 39/2004. (IV. 26.) ESzCsM decree.
- Strong understanding of GxP, GDP, quality systems, and local pharmaceutical regulations.
- Fluency in Hungarian and English.
- Structured, organized, and rigorous—able to prioritize and manage multiple activities.
- Excellent communication and relationship‑building skills.
- Strong problem‑solving mindset with a hands‑on, proactive approach.
- Comfortable working in a fast‑moving, highly regulated environment.
- Proficient in Excel; experience with digital quality platforms (e.g., Veeva Vault) is a plus.
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive package of benefits
- Flexible home office policy, with a possibility to work from home
- Access to internal recruitment and development libraries - you can create your own career path within Opella; your professional development will be supported purposefully
- Employee Assistance Program (mental health support, legal and financial consulting)
- Gender neutral paid parental leave as well as volunteer days.
Join us.
Health. In your hands.
