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Boehringer Ingelheim Associate Director, Quality & Compliance in Shanghai, China

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.

Responsibilities:

Quality strategy and governance:

  • 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。

Processes and Procedures:

  • Lead the implementation and maintenance of global procedures and ensure adherence to the local regulatory and business requirements

  • Collaborate with Medicine functions in conducting R/OPU learning needs analysis

Regulatory Inspections:

  • Lead inspections end to end (inspection preparation, conduct and post inspection management), representing the BI compliance position to regulatory authorities during inspections and ensuring inspection findings are addressed and responses provided

Audits:

-Contribute to audits from inputting into the annual audit planning and ensuring audit findings are appropriately investigated and actions are effectively implemented

-Conduct audit activities as lead-; co- or BI responsible auditor provided appropriate qualification is available, upon request (assignment) and under oversight of the global auditing leadership team

Risk and issue management:

  • Continuously review and evaluate standards and processes for potential compliance gaps / risks / near misses in accordance with regulatory and legal requirements e.g. use Functional Quality Assessments to communicate to global GPO and update as required.

  • Provide quality analysis, trending and optimization capabilities across Medicine Functions.

  • Lead as the subject matter expert (in partnership with the business key stakeholders) in Non Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation and CAPA development delivering robust CAPAs.

  • Be a proactive member of the project team and Contribute holistic Quality and Compliance input as a Project Quality and Compliance Lead (PQCL) at the project/trial level, provided appropriate qualification is available and under the oversight of global.

Requirements:

  • Master's degree preferred or Bachelors in a life science or other scientific discipline

Knowledge:

  • QMS: understanding of the sub-elements of QMS and how they link together such that role can fulfil QMS related accountability (see above)

  • Quality by Design: in depth knowledge of QbD approaches such that role can provide appropriate QbD related advice in relation to QM and functional processes

  • R&D understanding: understand overall drug development process and BI specific areas of focus (therapeutic areas) such that role can incorporate these topics whilst delivering accountabilities

  • External regulations: knowledge of the relevant regulatory requirements for QM and functional processes to be able to assess the risks for non-adherence to external regulations and provide mitigation strategies or how to address issues

Preferred Skills:

  • Communication skills: able to communicate effectively clearly and concisely with all individuals across BI regardless of their position or relationship.

  • Influencing & negotiating skills: able to clearly articulate options and their potential implications and reach an agreement with all individuals across BI regardless of their position or relationship.

  • Leadership skills: able to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities effectively.

  • Critical thinking: able to draw reliable conclusions in order to make decisions or recommendations.

  • Presentation skills: able to design and deliver effective presentations to achieve the required outcomes.

  • Risk management: able to identify and manage risks effectively.

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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