Senior Manager, Quality & Compliance
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Responsibilities
- Leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.
- Initiates and manages any quality and compliance topics to continuously improve our Quality Management System.
- Provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within a specific (R)OPU.
- Contributes R/OPU insights into the Global Quality Medicine Strategy and execute the strategy at R/OPU level.
- Develop and maintain all aspects of the global Quality Management System and tailoring to the (R)OPU to comply with local regulatory requirements.
- Leads with the Head of QM the preparation of Quality Management Review reports and meetings
- Active collaboration in the set-up, development and implementation of quality objectives and Quality plans
Qualifications
- Expert in ICH GcP and applicable regulations (10-12 years experience in clinical trial management and/or in depth knowledge of clinical development process) or expert in ICH GvP and applicable regulations (8+ years experience in pharmacovigilance and/or in depth knowledge of pharmacovigilance processes)
- Broad knowledge in applicable processes, procedures and systems Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies
- Direct experience with / participation in regulatory authority inspections
- Experience with working within a highly matrix environment / organization
-5+years experience in Quality and Compliance related job