Manager QA Operations

About the Position

Manager QA Operations

Join Grünenthal's Global Operations team as a Manager QA Operations in Quito, Ecuador. Ensure pharmaceutical quality standards and compliance.

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Responsibilities

• Driving and strengthening the Pharmaceutical Quality System across all GMP-relevant areas within the manufacturing site.
• Promoting a strong quality culture and ensuring compliance with international GMP regulations and corporate quality standards.
• Managing and closing quality events, deviations, Out-of-Specification (OOS) results, complaints, reworks, and technical quality investigations.
• Coordinating CAPA management activities and ensuring timely implementation of corrective and preventive actions.
• Leading Quality Committee meetings and providing quality system performance data to technical teams and leadership for decision-making.
• Monitoring and reporting Global Quality KPIs to local and global stakeholders.
• Maintaining quality procedures in line with international cGMP regulations, including EMA, FDA, ICH, and other applicable requirements.

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Requirements

• Bachelor's degree in Pharmaceutical Chemistry, Chemical Engineering, or a related scientific discipline.
• More than 5 years of experience in Quality and/or Manufacturing functions, preferably within the pharmaceutical, food, or consumer goods industries.
• Strong knowledge of GMP regulations and quality standards, including EU GMP Guidelines, FDA regulations, ICH guidelines, and ISO standards.
• Proven experience leading quality investigations, CAPA systems, quality risk management, and compliance activities.
• Advanced English proficiency, both written and spoken.
• Advanced proficiency with Microsoft Office applications, including Excel, PowerPoint, Word, Outlook, and internet-based tools.
• Strong analytical and technical decision-making capabilities.
• Leadership behaviors aligned with our values: patient focus, entrepreneurial spirit, collaboration, integrity, and performance orientation.

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We Offer

• Opportunity to work with a global leader in pain management and related diseases.
• Be part of a science-based, privately-owned pharmaceutical company with a long track record of innovation.
• Join a team focused on a vision of a world free of pain.

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About the Company

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.

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Meet our teams

Website: www.grunenthal.com

LinkedIn: Grunenthal Group

Instagram: @grunenthal