On behalf of our customer, a smaller pharmaceutical start-up group with a regional headquarter located in the Zug/Switzerland area, we are seeking the Head of Quality Management (f/m):

Responsibilities:

• Report to the VP Regulatory Affairs & Quality
• Ensure that the group complies at all times with all national and international laws, regulations, industry standards and internal processes regarding Quality Management
• Support national and international audits and inspections relating to Quality
• Responsible for review of documents, and release process required, for production of APIs, intermediates and finished products
• Responsible for quality audits of suppliers, vendors, manufacturers and distribution services utilized for products
• Ensure that company and its suppliers maintain compliance with all relevant GMP, GDP, GLP requirements regarding the manufacturing, testing, packaging and distribution of products
• Responsible for the preparation and conduct of all health authority inspections at the group’s facilities
• Responsible for direct interaction with suppliers during health authority inspections at their facilities
• Coordinate and prepare, in collaboration with other relevant departments such as Regulatory Affairs or CMC, responses to health authorities regarding findings (form 483 FDA)
• Review documentations, processes and procedures relating to activities, including identifcation of issues and problems, assessment of compliance and communication of findings to senior management
• Responsible for coordinating and directing activities involved in product recall, field alerts or product complaints
• Implementation and upgrading of Quality’s electronic documentation system containing internal policies, procedures and controlled documents
• Maintain the document control function for all GxP, including related documentation
• Monitor relevant Quality aspects of the Track and Trace system which is being implemented to comply with FDA’s DSCSA
• Ensure establishment of adequate GxP SOPs and policies, and provide guidance
• Conduct training on policies and SOPs
• Participate in special projects, as assigned

Requirements:

• Master of Science in a health-related field
• +12 years experience in the Quality Department of a biotechnology or pharmaceutical company, at least partly gained in Switzerland
• Strong knowledge of Swiss, EU and international GxP regulations; knowledge of 21 CFR part 11 requirements would be a plus
• Fluency in English and German; other languages would be a plus
• Proficient in MS Office Suite
• Excellent communication and presentation skills
• Excellent organizational skills and attention to detail
• Ability to interact effectively with all levels of associates both internally and externally
• Proven ability to manage projects, teams or personnel of significant scope and complexity, while meeting deliverables and timelines
• Demonstrated leadership and project management skills

Workplace: Zug