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Associate Director, Quality Control-236260
Talent@Boehringer Ingelheim https://www.boehringer-ingelheim.cn/
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, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
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, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
Job Responsibilities
- Leadership of Quality/Knowledge Management in ROPU TCM:
- Drive all quality initiatives within CD&O including cultivate quality culture, quality improvement activities, inspection readiness, etc.
- Implement effective knowledge management in alignment with global CD&O including training and knowledge management documents
- support and maintain global quality and compliance requirements in accordance with and in addition to local regulatory requirements, local codes of conduct, etc.
- Be Responsible for providing strong leadership that is aligned to the HPBU intent, Medicine and CD&O vision, strategies, goals, and operating model to ensure successful delivery (speed & value) of clinical trials in the team.
- Be Responsible for the execution, delivery and oversight of high-quality clinical trials that meet pipeline commitments, specific scientific medical, and regulatory requirements in the team. Responsible for team performance oversight and excellence.
- Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk talking and one common CD&O identity.
Quality Objective and Improvements
Inspection Readiness & Audits
NC and CAPA management
Knowledge Management
Process Optimization
Team Management
Qualifications
Minimum 10 years of experience in clinical research.
Minimum 2 years' experience in people management
Experience in managing studies and teams across multiple countries/regions Excellent organization skills
Excellent communication and negotiation skills Excellent cross-functional working ability
Solid understanding and application of performance, productivity and quality metrics Strong leadership
Independent judgment and decision making with respect to functional responsibilities Good command of written and verbal English
The North Star Provider: Leading matrixed internal teams (ability to influence without authority), proven managerial skills
The Supporter & Connector: Develops and empowers individuals & builds effective teams The Customer Value Driver: Ability to actively engage with customers, building strong customer relationships and delivering customer-centric solutions.
Stakeholder management: Ability to effectively build and manage relationships with different stakeholders internally and externally, engaging with them in a planed and meaningful way in pursuit of the company’s strategic objectives and feeding intelligence back to the company to maximize the deliverables.
Effective Communication & Influencing Skills: Ability to have a positive impact on others, to persuade or convince them in order to gain their support.
Effective cross-functional collaborations: Ability to develop and maintain relations, alliances and coalitions within and outside the organization and to use them in order to obtain information, support and cooperation
Curiosity, innovative thinking: Ability and a strong desire to know or learn something, inquisitiveness, interest, curiousness.
Digital acumen: Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
Integrity and compliance mindset: Adherence to the standards, values and rules of conduct associated with one’s position and the culture in which one operates.
Visionary & Innovator: Pro-active and agility to take direct action courageously in order to attain or exceed objectives.
工作 - 临床运营
主要地点 - Africa, Asia, Australasia-CN-上海-上海
组织 - 勃林格殷格翰(中国)投资有限公司
编制 - 全职