Beschreibung

In this role, you will lead the evolution of Quality Management Systems while ensuring compliance with global regulations. Your day-to-day responsibilities will involve driving cultural transformation, mentoring teams, and collaborating across departments to uphold stringent quality standards.

Anforderungen

• •Proven experience in a GMP-regulated environment
• •Leadership in building, optimizing, or remediating Quality Management Systems (QMS)
• •Strong track record managing end-to-end quality processes
• •Deep understanding of aseptic processing principles
• •Exceptional leadership skills
• •Ability to build and foster a strong quality culture
• •Strong experience working closely with manufacturing, tech ops, and supply chain teams
• •Excellent communication, negotiation, and influence skills
• •Strategic thinker with a pragmatic approach to problem-solving
• •Strong analytical skills for data-driven decisions

Aufgaben

• •Lead the development and optimization of Quality Management Systems (QMS)
• •Ensure compliance with global GMP regulations (FDA, EMA, ICH)
• •Manage core quality processes including deviations and CAPAs
• •Oversee change control and document management
• •Maintain comprehensive audit readiness
• •Apply aseptic processing principles and contamination control strategies
• •Drive cultural and operational transformation initiatives
• •Foster a strong quality culture in a fast-paced environment
• •Ensure accountability for quality across cross-functional teams
• •Integrate compliance goals with broader business objectives
• •Mentor and develop Quality Assurance professionals
• •Collaborate with manufacturing, technical operations, and supply chain teams
• •Engage and communicate effectively at all organizational levels
• •Lead through influence and manage resistance to change
• •Streamline QA processes while maintaining compliance
• •Make data-driven decisions and apply risk management principles

Benefits