Description

In this leadership role, you will drive operational excellence by overseeing complex quality management and cGMP compliance across the company's Bern site to ensure the delivery of life-saving therapies.

Requirements

• •8+ years experience in similar role
• •High independence and self-directed learning
• •Knowledge of cGMP and Compliance
• •Engineering and maintenance operations expertise
• •Experience with utility monitoring programs
• •Material management, warehousing, and logistics
• •Quality control and analytical methods
• •Change control management skills
• •Deviation management skills
• •CAPA management skills
• •Strong collaboration and networking skills
• •Coaching and mentoring skills
• •Excellent communication and technical explanation
• •Strong influencing and presentation skills

Tasks

• •Provide quality oversight for maintenance and utilities
• •Oversee quality control and warehouse operations
• •Manage qualification activities for operational and re-qualification projects
• •Ensure operational quality management follows cGMP standards
• •Review and approve complex GxP documentation
• •Support and approve quality risk assessments
• •Manage non-conformances, investigations, and CAPAs
• •Oversee complex change control processes
• •Monitor quality performance metrics to drive improvements
• •Lead complex cross-functional and global projects
• •Act as Subject Matter Expert during inspections
• •Collaborate with global quality assurance support functions
• •Drive quality decisions with diverse internal stakeholders
• •Conduct warehouse floor tours to address improvements
• •Implement new Quality on the Floor activities
• •Manage complex deviations at local and cross-site levels
• •Serve as Quality Delegate for change management
• •Review and complete raw material data for APR/PQR
• •Lead cross-functional Tier 1 operational meetings
• •Coordinate and deliver GMP training for new employees
• •Present quality investigations to health authorities

Tools & Technologies

Benefits