Qms Lead

il y a 2 semaines

Gent, Belgique Argenx Temps plein

About argenx

Purpose of Function

To drive a culture of process improvement across the organization

To work closely with colleagues from the business at all levels to create and maintain lean, easy to follow, compliant processes

To ensure the argenx quality management system and framework reflects both the internal and external requirements and regulations

Main Responsibilities
- Build a sustainable Quality System framework capable of supporting a rapidly progressing pipeline and growing organization
- Develop and implement streamlined processes and procedural documents compliant with regulatory, industry, and internal quality standards that meet global and local needs (e.g. Pharmacovigilance, Medical Affairs, Healthcare Compliance)
- Facilitate Process Development and optimization projects for argenx activities at global level and for local markets
- Support the development and implementation of local QMS in argenx Local Operating Companies striving for global alignment, consistency and efficiency whilst allowing compliance with local regulations
- Help teams build high-quality, standardized processes that consistently deliver intended outcomes
- Drive improvements and the implementation of standards in a fast-paced growing environment in collaboration with internal stakeholders
- Provide oversight for the development and maintenance of the Quality management systems and related electronic systems, processes and procedures that ensure compliance with internal and external standards.
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Work directly with Local Operating Companies to provide process analyses oversight on a continuing basis to ensure local requirements are met.
- Support inspection readiness and inspection management
- Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits
- Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external
- Facilitate uniform standards worldwide and enable best practice sharing, in line with the company's global ambitions.

Desired Skills & Experience
- 6+ years’ experience within GxP Quality Management
- Excellent knowledge of GxP and regulatory requirements
- Critical analysis and synthesis of evolving quality regulation
- Experience partnering with cross-functional commercial and technical teams
- Expert in QMS Optimization
- Proven track record in procedural document management and process mapping
- Experience in Quality analysis and Quality management
- Demonstrated Project Management skills
- Team player and good communication skills with a strong level of self-motivation
- Quality-minded individual with a strong customer focus who is accurate in execution and reporting
- Flexible attitude, capable of picking up the tasks that require attention
- Fluent in English - our working language

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