QA Manager Country Quality Lead EMEA
Secteur : Industrie du médicament humain Famille de fonction : Contrôle qualitéDescription du poste et des missions
In the context of team expansion within EMEA, we are looking for a QA Manager.The purpose of this role is to ensure robust quality oversight and compliance with GxP’s and local regulatory requirements across the countries and affiliates assigned. 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), while supporting business continuity and driving continuous improvement. QA Manager Country Lead will act as a subject matter expert on international pharmaceutical legislation, providing guidance to the organization. Additionally, this role is responsible for fostering and maintaining quality awareness throughout the organization.
Profil souhaité
Key responsibilities
- Ensure compliance with corporate policies, local regulations, and GDP standards across assigned affiliates.
- Oversee and maintain the Quality Management System (QMS) to ensure consistent procedures and processes.
- 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 to safeguard product integrity.
- Develop mitigation plans for risks associated with distribution channels to prevent product quality incidents.
- Deliver quality and compliance training to affiliate/s staff, ensuring understanding of GDP/GxP and corporate expectations.
- Collaborate with internal stakeholders (Manufacturing, PV, RA, SC) and foster relationships with local regulatory authorities.
Compétences requises
EXPERIENCE
- 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, French and Spanish
DESIRABLE
- Knowledge of medicinal products and medical device regulations at EU and international level
- TrackWise and Veeva quality application user knowledge
