Manager QA Operations
On-siteQuito, Pichincha, Ecuador
Job Summary
Drive and strengthen the Pharmaceutical Quality System across all GMP-relevant areas within the manufacturing site while promoting a strong quality culture and ensuring compliance with international GMP regulations. Manage and close quality events, deviations, Out-of-Specification results, complaints, reworks, and technical quality investigations, coordinating CAPA management activities to ensure timely implementation. Lead Quality Committee meetings and provide quality system performance data to technical teams and leadership for decision-making, monitoring and reporting Global Quality KPIs to local and global stakeholders. Maintain quality procedures in line with international cGMP regulations, including EMA, FDA, ICH, and other applicable requirements.
Required Qualifications
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.