Quality Management System (QMS) Lead

工作内容

About the company

Our client is a global immunology company developing antibody-based medicines for patients

suffering from severe autoimmune diseases and cancer. By translating immunology

breakthroughs into innovative drug candidates, the company is building a world-class portfolio of firstin- class antibodies in both early and late clinical stages of development.

Purpose of the 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 company’s 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 the company’s activities at global level and for local markets
• Support the development and implementation of local QMS in the company’s 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