In a nutshell
Position: Director of Quality Assurance
Location: Paterna (Valencia) – On-site
Experience: 5+ years in quality leadership within pharmaceutical FDF manufacturing
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Want to know more?
BioNanoPharma is committed to excellence in the development, manufacturing, and distribution of innovative pharmaceutical products. Our mission is to ensure the highest standards of quality and safety at every stage, with a strong focus on continuous improvement and sustainability. Would you like to join a team that is leading the transformation of the healthcare sector?
Ready to be a #Challenger?
What are we looking for?
We are seeking a Director of Quality Assurance to lead and oversee the implementation of quality programs across all BioNaNopharma operations, ensuring regulatory compliance and continuous improvement. You will be the key reference for quality, acting as Deputy QP and substituting for the Technical Director of Quality when required.
The challenge!
* Develop and maintain the Quality Management System (QMS) in line with international standards.
* Manage quality documentation: SOPs, work instructions, and records.
* Plan and execute internal and external audits, ensuring readiness for regulatory and client inspections.
* Ensure compliance with GMP, GDP, FDA, and industry standards.
* Oversee the acquisition and maintenance of certifications and licenses.
* Identify and mitigate compliance risks in the supply chain and storage.
* Conduct regular warehouse inspections, monitoring temperature and storage conditions.
* Implement quality controls in inventory and logistics processes.
* Develop protocols for temperature-sensitive products.
* Manage quality in freight forwarding operations and external providers.
* Investigate incidents and lead corrective and preventive actions (CAPAs).
* Drive continuous improvement using Lean/Six Sigma methodologies and KPIs.
* Foster a culture of quality and design training programs for the team.
* Collaborate with operations, logistics, and customer service to align quality objectives.
* Manage customer complaints and lead root cause analysis.
* Report to senior management on quality performance and areas for improvement.
What do you need?
* University degree in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, or Biology.
* At least 5 years of experience in a quality leadership role within a pharmaceutical FDF manufacturing site.
* Experience with GMP, GDP, and FDA regulations (FDA experience is a plus).
* Quality-related certifications (ISO 9001 Lead Auditor, Six Sigma Black Belt, GDP Certification) are highly valued.
* Advanced knowledge of quality systems management and audits.
* Fluent in Spanish and English.
* Strong leadership, communication, analytical, and stakeholder management skills.
Our benefits!
Permanent contract
Professional development and continuous training
Private health insurance
Subsidized canteen
Free parking
Additional social benefits
What is the selection process like?
* Initial contact by phone or email.
* 1-2 on-site interviews with HR and the Technical Management team.
* Ongoing communication about your application status.
Think this role isn't for you?
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#BioNaNopharma #Challenger #QualityAssurance #InsudTalent
COMMITMENT TO EQUAL OPPORTUNITIES
At BioNanoPharma, we promote equal opportunities and non-discrimination based on gender, ethnicity, religion, sexual orientation, disability, or any other condition. xohynlm We believe diversity drives innovation and growth.