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
- 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

- Be a quality & compliance consultant and work collaboratively as a solution oriented, pragmatic partner to the Medicine functions and other applicable business partners, leading them to understand the quality and compliance requirements and implications for their business area

- Assess impact of Regulatory Intelligence Network (RIN) changes on Quality and Compliance processes and act and escalate topics accordingly

- Lead the understanding of Quality Culture by ensuring quality and compliance standards are understood and embedded into processes and practices early (Quality by Design)

- Active involvement and participation in local/ global/regional activities/topics and projects

Qualifications

- Expert in ICH GcP and applicable regulations (8+ 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 company 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