Quality Assurance Responsible
Summary
Oversee quality for external pharma manufacturers, ensuring GMP compliance, audits, and CAPA processes to safeguard product safety and regulatory standards globally.
Quality Assurance Responsible, External Manufacturing API
Location: Budapest, Hungary
You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Supply Chain Lead, External Manufacturing API, you’ll bring your expertise, leadership, and drive to ensure reliable supply, strengthen strategic partnerships, and support the delivery of trusted self-care products worldwide.
About the job
In this role, you will provide Quality oversight for Opella's External Manufacturing API network, ensuring compliance, product quality, and patient safety across a complex global supplier landscape. As a key partner to Supply Chain, Regulatory, and External Manufacturing teams, you will help ensure that Active Pharmaceutical Ingredients are sourced, managed, and distributed in accordance with applicable quality standards and regulatory requirements
Main responsibilities:
Oversee Quality activities for external manufacturers, ensuring compliant operations and effective Quality agreements
Monitor performance through KPIs and drive continuous improvement initiatives
Manage deviations, change controls and CAPAs in a timely and compliant manner
Identify, assess and mitigate risks related to raw materials, components and finished products
Ensure proper handling of product complaints from global markets
Support audits, self-inspections and implementation of Quality standards
Collaborate cross-functionally to support product launches, transfers and new business opportunities
About you:
Background in Quality Assurance, Quality Control or Manufacturing within pharma/healthcare; exposure to external manufacturing is a strong plus
Strong communication, problem-solving and stakeholder management skills; able to work effectively in cross-functional and international teams
Proactive, collaborative and solution-oriented, with a risk-based approach
Understanding of GMP and Quality systems; experience with deviations, CAPA and audits
Degree in Pharmacy, Pharmaceutical Sciences or related scientific field (PhD is a plus)
Fluent English (written and spoken)
Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.
This is more than the next step in your career, it’s a chance to lead a critical part of Opella’s global supply network and help ensure millions of consumers have access to trusted self-care products. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.
About Us
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 is 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 are our 100+ loved brands, our 11,000-strong global team, 13 best-in-class manufacturing sites, and 4 specialised science and innovation development centres. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale, and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and a healthier planet.
Learn more at www.opella.com
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