Shanghai, CHN
13 hours ago
Head of Quality, Medicine TCM
**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. **Purpose of the Job:** + To lead implementation of the BI Medicine QMS consistently, effectively and efficiently within the (R)OPU according to global strategy in order to ensure compliance with regulations, procedures and processes within Medicine. + Ensure BI Medicine can meet regulatory requirements. + To lead the (R)OPU Quality Medicine organisation, ensuring appropriate skills and competencies. + Active membership of the (R)OPU medical leadership team to ensure alignment across functions, appropriate implementation of the QMS and regular review of quality status in the (R)OPU. + Ensure identification and proactive communication of all relevant information from the (R)OPU to Head of Regions, Quality Medicine, in order to ensure global oversight of quality topics and continuously improve the global quality management system for BI Medicine. + To lead by example and to be accountable for fostering a culture that promotes continuous learning. + Ensure appropriate engagement with relevant industry associations in order to proactively contribute to discussions on quality topics and deliver quality improvements. + Lead cross-functional quality discussions to identify synergies and optimise the global BI quality management system. + This could include (but is not limited to) interactions with quality functions + For those (R)OPUs with colleagues in global knowledge & learning (e.g. global trainers) and/or global compliance functions (e.g. project compliance managers: + Ensure alignment with the respective global head to actively support talent management of the colleagues in these roles and information sharing with the colleagues performing global roles. **Requirements:** + Master or Doctor in Pharmaceutics, Medicine or other relevant functional area. Certification in Quality Management. + Skill: + Extensive experience of GCP/Pharmacovigilance quality management systems + Significant experience of leading OPU teams + Significant experience of interacting with Regulatory Authorities e.g. regulatory inspections + Language Skills & Proficiency: English (Read: fluent;Write: fluent;Speak: fluent) + Experience: + Years of leadership experience: 4-6 years leading employees, leading leaders, leading projects, leading business/functions + International Experience: Y + Special Working Experience: + International working experience mandatory for Heads of Quality Medicine (R)OPUs with multiple countries. + Experience of working in a quality function. + Experience in a function other than Quality Medicine (e.g. Clinical Operations, PV, Medical Affairs, and Operations). + Knowledge of Quality Management Systems. + Knowledge of Medicine functions. + Competencies: + Leadership Competencies + Advanced communication skills including assertiveness and coaching and mentoring. + Intercultural competence. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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