General Summary
As a Site Quality director, you will ensure compliance with Organon Policies and global industry standards, establish processes for regulatory trends, and guarantee product quality, efficacy, and safety. You will promote continuous improvement in quality processes, manage internal audits, provide training and guidance, and maintain effective data systems. Leading and empowering the quality team, you will drive operational excellence and manage the quality area budget to align with business needs. Your expertise in GMP, regulatory requirements, and quality management will be crucial in driving continuous improvement and innovation. Join us to make a significant impact on our commitment to delivering safe and effective products.
- This is a fully Onsite role with base in Xochimilco.
- Please note that this position does not offer relocation support. Candidates must be willing to work from the specified location and should not expect any assistance with moving or housing arrangements.
Responsibilities
- Ensure the development and implementation of quality assurance policies and procedures to guarantee compliance with Organon Policies and general industry standards. Establish processes for the periodic review and implementation of local and international regulatory trends in manufacturing, packaging, supply chain, and operations.
- Ensure that all products comply with the regulatory requirements of the markets where our products are distributed, including FDA guidelines. Guarantee the quality, efficacy, and safety of all products, and ensure that quality requirements for outsourced products and services are clearly defined through quality agreements.
- Establish a culture of continuous improvement to optimize quality processes, systems, and methods, improving productivity and service levels for internal and external customers.
- Ensure that the site has a robust internal audit process to manage inspections and ensure compliance with qual
📌 Site Quality Director (Xochimilco)
🏢 Organon
📍 Xochimilco
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