Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Purpose: Establish sophisticated Quality Management (QM) framework in China R&D that consists of quality elements such as processes, issue management, risk management and knowledge management
Ensure clinical studies are conducted in China with high quality and in compliance with regulatory requirements and standard procedures by adopting the above QM framework
Responsibilities:
- Exercise leadership over discussions regarding quality in China and contribute to maintaining high level of quality
- Develop, maintain, and oversee the quality system and associated strategy, processes, tools, and technologies
- Perform local business process management in alignment with global/local regulatory requirements
- Lead impact assessment (IA) discussions around new/updated local regulations as well as Global QSDs in collaboration with the IA team members
- Identify training needs based on data-driven decisions. Plan and provide instructor-led training needed from a QM perspective targeted for China R&D and/or Global audience as applicable
- In consultation with China R&D leadership, review and refine training curriculum for local roles in the Learning Management System
- Provide advice to China R&D including global/local clinical processes, procedural documents and on international guidelines such as ICH-GCP, industry standards and local regulations
- Explore more efficient ways in improvement of quality and implement that in collaboration with stakeholders through process management, training and other quality activities
- Lead audit response management and review quality issues and audit/inspection CAPAs to ensure suitability
Qualifications
- Bachelors or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy) preferred
- At least 7 years of experience in the pharmaceutical industry, preferably in development operations/quality management
- Demonstrate leadership and promote projects by inspiring and involving the stakeholders
- Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R3
- English communication skill, TOEIC score of 850, or equivalent capability
- Broad knowledge of global process and Chinese local regulatory requirements related to clinical studies
- Ability to lead GCP inspection readiness activities and support global health authority inspections
- Strong knowledge management, project management and change management skills
- Strong data insights and analytical skills to identify trends and drive quality / process improvements
- Leadership Behavior/Mindset
- Never satisfied with the status quo and always pursue improvements
- Look from the other person's point of view and address issues together
- Communication skill to maintain a comfortable relationship with other functional areas and drive the business in collaboratio
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html