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.
Job Responsibilities
The Quality and Compliance Senior Manager/Associate Director is the Quality and Compliance expert and drives GvP / GcP topics across the Boehringer Ingelheim organization to pro-actively manage Quality and Compliance across the drug/device lifecycle.
•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 Quality Management on the preparation of Quality Management Review reports and meetings
- Active collaboration in the set-up, development and implementation of quality objectives and Quality plans
•Culture and organization:
- 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
•Processes and Procedures:
- Lead the implementation and maintenance of global procedures in a pragmatic, clear and concise way and ensure adherence to the local regulatory and business requirements. For example, lead the design / creation / retirement of local documents/ KMED assets as required
- Collaborate with Medicine functions in conducting R/OPU learning needs analysis (training, qualification)
•Regulatory Inspections:
- Lead inspections end to end (inspection preparation, conduct and post inspection management), representing the Boehringer Ingelheim 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 optimisation 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.
Job Requirements
- Master's degree preferred or Bachelor's degree in a life science or other scientific discipline.
Knowledge:
- QM processes and functional processes: level of understanding such role can provide appropriate Quality and compliance related advice in relation to the QM processes.
- 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.
- BI organization & strategy: understand the BI organization and our goals such that role can incorporate these topics whilst delivering accountabilities e.g. considering strategy and goals when providing advice within (R)OPU.
- 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.
- Digital suppliers: understand digital supplier such that role can incorporate these topics whilst delivering accountabilities e.g. provide advice on risks to data integrity through use of specific supplier and suggest ways to mitigate these risks.
- New technologies: knowledge of specific technologies e.g. data collection technologies and the associated (potential) regulations, such that role can provide advice in their use within the (R)OPU.
- 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 Boehringer Ingelheim 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 Boehringer Ingelheim 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.
- Data analytics: able to perform simple analyses and interpretation of data in order to enable decision making and to identify recommendations.
- 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.
-Project management: able to apply project management techniques to lead and deliver local or regional projects.
-Be fluent in English communication
-Clinical Quality Assurance experience is essential, GCP/GVP/GLP auditor experience is preferred