AD/ Sr Manager- Medical Quality lead
Job requirements /工作要求
- Academic / Professional qualification / 学 历 / 专 业 资
Bachelor degree in medical or pharmaceutical sciences required
- Technical / skill training / 技 术 / 技 能 训 练
Knowledge in medical affairs activities/ GCP/ GVP
- Working experience (No. of years / 年 资, Job function / 工 作 功 能, Business types / 业 务 种 类 )
At least > 5 years multinational pharmaceutical company working experience
Fluent in Mandarin and English
Good at office
DUTIES & RESPONSIBILITES/ 主要职责
1. Ensure MA activities in compliance
- Regular review on compliance procedures, MA related procedures and management platforms with the aim of continuous improvement in the quality of MA activities
- Set a system of regular self-checking with timely completion of corrective actions
- Develop annual QA plan which is agreed by MA leadership team
- Execute event/project and system QA according to the annual QA plan
- Regular review on the cross-function Quality Control status in MA and provide periodic reports to MA leadership team on compliance status
- Provide recommendation to Medical QC Manager for root cause analysis and contingency/remedy plan
- Initiate risk management process in MA
- Develop, maintain and document the processes and procedural documents on MA ownership according to global and local procedures.
- Organize the trainings as the owner of all MA SOPs and guidance.
- Coaching QC mgr on quality management
- Organize case sharing and feedback learning
- Contact person for global audit and local inspection (non-GVP, non-GCP)
- Organize medical affairs internal mock audit
- Significant and general audit findings and QA findings reduces year on year
- Compliance with local legislation, codes of Conduct/Practice and AstraZeneca internal standards as measured by internal quality checking and audits of materials and activities.
- Feedback from QC personnel, line manager and MA leadership team
- Feedback from presentation/ training sessions
2. Ensure effective operational implementation of the QMS across all GxP areas in AZ China
- Organize monthly cross GxP QMS meeting
- Proactively communicating compliance trends and risks to the GxP Country Quality Lead
- Provide and/or coordinate the required trainings in the GxP area
- Coordinate GxP self-assessments performed internally by the MC personnel to ensure adherence to procedures and standards
- Monitoring all relevant KPIs. They include global KPIs already established and communicated regularly by the global functions but also local KPIs (defined in the MC, based on risks and improvement areas)
- AZ China GxP Quality Manual is up to date
- Self-assessment is conducted per annual plan
- CIPs is fully implemented
- Feedback from GxP Quality Leads
COMPETENCIES / 胜任能力
Skill and Job requirements:
- Understanding of the working scope of the functions in Medical Affairs
- Sound knowledge of international and RDPAC medical compliance legislation, codes of practice and their practical application.
- Knowledge and experience of corporate governance are desirable.
- High ethical standards. An understanding of ethical decision making processes and an ability to discuss ethical and regulatory issues with credibility and authority.
- Strong strategic thinking, independence and analytical skills
- Excellent communication and presentation skills.
- Good interpersonal, influencing, networking and coaching skills, to interact effectively across different functions, seniority levels and cultures within the Company and externally
- Sets high ambitions and demands excellence from team
- Set up consistent high performing team over time
- Consistently improving all team members performance
- Able to advise and coach other managers on their coaching skills
- Proactively support career opportunities mapping for high performers
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.