Compliance Manager

Janssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. 

For the Clinical Manufacturing and Technology (CM&T) organization located in Schaffhausen, Switzerland we are looking for a 
 

Compliance Manager (f/m/d)
 

In this position, you will support CM&T organization as part of Therapeutic Development and Supply R&D for parenteral manufacturing and combination products in all compliance aspects for internal and external production to ensure timely clinical supplies of clinical trial material. 

Responsibilities:

• Management of the CM&T Compliance Team and member of the CM&T management team
• Campus quality core team member for integrated compliance processes
• Ensures timely delivery of clinical material from the fill finish pilot plant and clinical contract manufacturing organization in close collaboration with quality assurance
• Responsible for training curricula of all CM&T employee and training coordination for CM&T 
• Responsibility for cleaning and disinfection activities and supervision of cleaning and disinfection team (external supplier) in alignment with campus strategies
• Responsible for cleanroom gowning concept of Pilot Facilities and ensure gown availability in alignment with the campus and in close collaboration with the external supplier
• Development of APS strategies for new technologies, training, qualification of personal and documentation in compliance with regulatory requirements
• Subject matter expert and single point of contact to QA for internal/external audits, audit preparation and ensure inspection readiness for Pilot Facilities
• Supports environmental monitoring of cleanrooms in collaboration with QC labs to ensure product safety and Annex 1 requirements
• Leads and supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents 
• Microbiological & Sterility Assurance PAT subject matter expert for assessment and implementation of new technologies
• Preparation and tracking of KPIs cross-functional for the management to ensure production and business requirements 
• Cross functional collaboration with internal and external partners (QA, QC, Site-Engineering and Technical Operations)
• Actively participates in individual or team-based scientific development activities and collaborate in internal / external scientific communities