Company Overview : Our company is a well-established specialist in the field of allergy diagnostics and treatments, offering an extensive portfolio of high-quality products designed to improve the quality of life for patients suffering from allergic diseases. With decades of experience and a strong reputation for scientific excellence, patient focus, and regulatory compliance, we are committed to supporting healthcare professionals and patients with trusted and innovative solutions.
Position Summary : We are seeking an experienced and committed Quality Director to lead and oversee all Quality Assurance (QA), Quality Control (QC) activities, with strategic accountability for maintaining GMP compliance across manufacturing and laboratory operations. This role will also directly manage the Qualified Person (QP) team to ensure seamless batch release processes while driving continuous improvement of lifecycle management.
Reporting directly to the General Manager, you will ensure our operations continue to meet the highest standards of quality, compliance, and safety — supporting the delivery of products that meet both patient needs and regulatory expectations. This is a strategic leadership role, responsible for driving a quality-centric culture, ensuring compliance with applicable regulations, and maintaining robust quality systems in a regulated environment.
Key Responsibilities :
* Act as principal qualified person, leading the team of deputy qualified persons.
* Provide strategic and operational leadership to the Quality Assurance and Quality Control teams, ensuring alignment with company objectives and regulatory requirements.
* Ensure full compliance with applicable national and international standards, including EMA, FDA, NMPA and other relevant pharmaceutical authorities and regulatory frameworks.
* Lead, manage, and continuously improve the Quality Management System (QMS) to ensure its effectiveness in supporting the authority quality compliance, company quality policy, product quality, production sustainable, etc.
* Oversee product release processes, laboratory operations, deviation investigations, change control, CAPA, and supplier qualification programs.
* Act as the primary point of contact for regulatory inspections, customer audits, and certification bodies, representing the quality organization with confidence and credibility.
* Monitor and report quality performance through KPIs and dashboards, ensuring proactive identification and mitigation of risks.
* Collaborate cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Commercial teams to ensure quality is embedded across the product lifecycle.
* Lead and mentor the quality organization to strengthen technical expertise, foster continuous improvement, and maintain a strong culture of compliance and accountability.
* Contribute to company-wide initiatives in digital transformation, operational excellence, and innovation from a quality perspective.
Candidate Profile :
* University degree in Pharmacy, advanced degree is a plus.
* Minimum 10 years of progressive leadership experience in Quality Assurance and Quality Control, ideally within the allergy / immunotherapy sectors, biotech, or pharmaceutical.
* Minimum 10 years of QP experience in pharmaceuticals.
* Deep knowledge of NPP, GMP standards, and regulatory requirements applicable to biologics and allergy-related products.
* Demonstrated success in leading teams through regulatory inspections and third-party audits.
* Strong strategic thinking combined with hands-on leadership and excellent problem-solving abilities.
* Excellent communication skills in both Spanish and English.
* High integrity, attention to detail, and commitment to patient safety and product excellence.
* Good relationship with the authorities, especially with AEMPS.
What We Offer :
* A key leadership role within a respected, patient-centered organization.
* The opportunity to shape quality strategies and make a direct impact on the health and wellbeing of allergy patients.
* A collaborative and supportive working environment.
* Competitive compensation and benefits package.
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