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About the Role

This role is pivotal in driving the development, improvement, and monitoring of quality systems that support clinical supply operations. The candidate will bring deep expertise in quality systems, compliance, and continuous improvement, with a strong focus on documentation, training and metrics reporting.

Key Responsibilities

• Quality Systems Support: Provide Quality Systems support to External Clinical Supply Quality (ECSQ) and other CSQ departments as needed, including coverage during absences and peak workloads; serve as a Subject Matter Expert (SME) for Quality Systems processes.

• Development & Improvement: Support initiatives to improve CSQ quality systems in alignment with global standards and regulatory requirements. Collaborate cross-functionally to identify gaps and implement balanced solutions.

• Implementation & Monitoring: Ensure effective deployment of quality system processes across (E)CSQ.

• Monitor system performance and drive continuous improvement through data analysis and partner feedback.

• Training & Documentation: Develop and deliver ECSQ training programs to ensure consistent understanding and application of quality procedures. Maintain accuracy and completeness of quality records and documentation.

• Metrics & Reporting: Define, track, and report critical metrics for CSQ. Provide actionable insights to leadership based on data trends and compliance metrics.

• Compliance & Audit Readiness: Ensure CSQ operations are inspection-ready and compliant with internal and external standards. Support the development of the annual external suppliers’ audit plan.

Qualifications

• Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Engineering, or related field. Advanced degree preferred.

• Proven experience in pharmaceutical or biotech industry, with a focus on quality assurance and/or quality systems.

• Strong knowledge of GxP regulations, ICH guidelines, and global quality standards.

• Ability to support cross-functional initiatives and drive process improvements.

• Excellent communication, analytical, and organizational skills.

• Experience with electronic quality systems (e.g., COMET, Veeva, TruVault, SUMMIT or similar platforms) and data reporting tools (e.g., PowerBI, Quickbase, Tableau).

• English proficiency is a must.