Full-Time QA Manager Country Quality Lead EMEA

We are looking for a QA Manager to ensure quality oversight and compliance with GxP’s and local regulatory requirements across assigned countries. This includes the Iberia region, Italy and France.

The role involves:

• Collaborating with cross-functional teams to maintain and enhance the Quality Management System (QMS).
• Supporting business continuity and driving continuous improvement.
• Acting as a subject matter expert on international pharmaceutical legislation.
• Fostering and maintaining quality awareness throughout the organization.

• Ensure compliance with corporate policies, local regulations, and GDP standards across assigned affiliates.
• Oversee and maintain the Quality Management System (QMS).
• Monitor affiliate operations for alignment with EU and local regulations.
• Manage health authority inspections, audits, and self-inspections, including Product Quality Complaints, Deviations, CAPA, and Change Control.
• Ensure quality documentation aligns with corporate standards and regulatory requirements.
• Stay updated on local and EU regulatory changes, advising affiliates on necessary compliance updates.
• Investigate quality-related issues, implementing CAPAs, and conduct risk assessments.
• Develop mitigation plans for risks associated with distribution channels.
• Deliver quality and compliance training to affiliate/s staff, ensuring understanding of GDP/GxP and corporate expectations.
• Collaborate with internal stakeholders and foster relationships with local regulatory authorities.

Requirements:

• Degree in Pharmacy with appropriate experience
• Knowledge in relevant (European) regulations and guidance documents (GMP, GDP)
• Recognized experience by CNOP for Deputy Responsible Pharmacist (Exploitant)
• Minimum of 5-8 years of experience in quality assurance or quality management within the pharmaceutical industry, including experience within commercial quality.
• Good understanding of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and international regulatory requirements.
• Proven experience managing quality systems and quality investigations.
• Spoken and written languages: English and French
• Knowledge of medicinal products and medical device regulations at EU and international level (Desirable)
• TrackWise and Veeva quality application user knowledge (Desirable)
• Spoken and written language: Spanish (Desirable)

What is the last date for applying to the job?

Which countries are accepted for this remote job?