Full-Time QA Manager Country Quality Lead EMEA
Santen is hiring a remote Full-Time QA Manager Country Quality Lead EMEA. The career level for this job opening is Manager and is accepting Paris, France based applicants remotely. Read complete job description before applying.
Santen
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Purpose of Role:
Ensure robust quality oversight and compliance with GxP’s and local regulatory requirements across assigned countries and affiliates. Maintain and enhance the Quality Management System (QMS), support business continuity and drive continuous improvement. Act as a subject matter expert on international pharmaceutical legislation and foster quality awareness.
Key Responsibilities:
- Ensure compliance with corporate policies, local regulations, and GDP standards.
- 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.
- Ensure quality documentation aligns with corporate standards and regulatory requirements.
- Stay updated on 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 staff.
- Collaborate with internal stakeholders and foster relationships with local regulatory authorities.
Education:
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)
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.
Languages:
English and French
Desirable:
Knowledge of medicinal products and medical device regulations at EU and international level. TrackWise and Veeva quality application user knowledge. Spanish