Beschreibung

In the Head of Quality Assurance role, you will oversee quality activities and ensure compliance with regulations while driving continuous improvement. Your day-to-day responsibilities will involve collaborating with teams, managing quality documents, and leading a dedicated team to uphold high standards.

Anforderungen

• •Master’s degree or equivalent in natural science or pharmaceutical related area
• •8 or more years of experience in Regulatory Affairs
• •Extensive experience in regulatory affairs and knowledge of Swiss national regulations
• •Broad functional knowledge of pharmaceutical sciences and industry
• •Experience managing a team and leading a department
• •Experience working cross-functionally with other company functions
• •Proven track with Swissmedic interactions
• •Fluency in German and advanced proficiency in English

Aufgaben

• •Oversee quality-related activities in Switzerland
• •Serve as the contact person for all quality issues
• •Ensure compliance with regulatory requirements and internal policies
• •Drive continuous improvement initiatives
• •Maintain adherence to quality standards and objectives
• •Collaborate with cross-functional teams
• •Establish quality metrics and conduct audits
• •Provide strategic direction to enhance product quality
• •Handle non-conformance issues, complaints, and CAPA activities
• •Manage quality-related documents, including SOPs and specifications
• •Oversee supplier qualification for locally registered products
• •Ensure execution of self-inspection and GDP training
• •Manage change control activities
• •Ensure proper storage and handling of release samples
• •Archive quality management documentation according to Good Documentation Practice
• •Lead and manage quality assurance employees, setting goals and providing coaching
• •Control budget and cost center

Benefits