In a nutshell
Position: Deputy Technical Director of Quality
Location: Valencia
Experience: 5+ years in leadership roles within pharmaceutical FDF manufacturing
Want to know more?
BioNanoPharma is a global company committed to excellence across the pharmaceutical value chain, bringing innovation, quality, and expertise in research, development, manufacturing, and distribution of pharmaceutical products. Our mission is to improve health and well-being through advanced and sustainable solutions.
Ready to be a #Challenger?
What are we looking for?
As Deputy Technical Director of Quality, you will:
* Develop, implement, and maintain the Quality Management System (QMS) in line with industry standards.
* Manage quality documentation: SOPs, work instructions, and other key documents.
* Plan and execute internal and external audits, ensuring readiness for regulatory and client inspections.
* Ensure compliance with regulations (GDP, GMP, FDA, and other applicable standards).
* Oversee the acquisition and maintenance of required certifications and licenses.
* Identify and mitigate compliance risks across the supply chain.
* Conduct regular warehouse inspections, ensuring optimal storage and handling conditions, especially for temperature-sensitive products.
* Implement quality controls in inventory management and freight forwarding operations.
* Investigate incidents and manage corrective and preventive actions (CAPAs).
* Lead continuous improvement initiatives using Lean/Six Sigma methodologies.
* Define and monitor quality and operational efficiency KPIs.
* Foster a culture of quality and accountability throughout the organization.
* Design and deliver training programs on quality standards and compliance.
* Collaborate with operations, logistics, and customer service teams to align quality objectives.
* Address and resolve customer complaints, conduct root cause analysis, and implement corrective actions.
* Report to senior management on quality performance and areas for improvement.
* Act as a substitute for the Technical Director of Quality when required, ensuring continuity of leadership and quality standards.
* Perform QP activities and oversee batch release for clinical trial products.
The challenge!