上海招聘

Position Summary
Closely partner with Everest functions, customers, service providers, this position is responsible to achieve high level of quality and compliance for all projects under EVERID, by followings:
1. Effectively working with study team and relative functions as well as platform QA function to set up a quality measure system and also performing quality assessment for on-going or completed studies/ projects in all elements.
2. Driving the business in quality domain with continuously building or optimizing SOP/best practice/way of working in EVERID.
3. Performing quality control activities at project level and functional level,
4. Analyzingand reporting quality metrics and leading in quality improvement plan as well as the monitoring the execution
5. Organizing the training for employees to fulfil the job requirement together with Functional heads .
6. Leading the inspection readiness and making sure proper resources and process in placed for a good preparation in inspection and make sure any risk identified with a good mitigation plan executed.
Responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV). Implementation of the Everest Quality Manual and Quality Management System in the Medical Department to achieve a high level of quality and compliance.

Key Responsibilities

1. Quality control assessment for all on-going projects/studies through following focusing areas
1) Support in the issues analysis and problem solving with a cross-functional aligned action plan
2) Make sure proper documents through good process in placed with quality in documentation
3) Driving for sufficient route cause analysis and CAPA in placed as well as its execution
4) Vendor selection and management
5) Vendor quality oversight
2. Lead in SOP development and maintenance by working x-functionally
3. Provide and organize the training necessarily for SOP execution
4. Generate Quality Metrics and quality KPIs and evaluate functional wide quality risks
1) Assure that appropriate quality metrics are generated, monitored and reported to enable continuous performance improvements for the department and assist the business in making informed decisions.
2) Build and implement and maintain Quality System in the areas of GCP and GPvP together with Platform Quality function
3) Analyse trending based on the data of quality metrics
4) Ensure readiness for all GCP and GVP regulatory inspections.
5. Training and compliance
1) Develop new hire on-boarding GCP training slide decks, conduct and document ongoing Clinical Development GCP training
2) Assess training compliance status based on the assigned training curriculum
3) Ensure conduct of adequate training at the CO for all GCP and GPvP activities by defining, planning and supporting training activities.

Recommended Education and Key Competency
1. Minimum of bachelor’s degree or equivalent in scientific or life science discipline; Master's Degree preferred
2. At least 6-10 years of experience in clinical research and development
3. At least2 years of experience in quality management including QC
4. Track record of establishing effective business relationships with internal and external customers
5. Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
6. Fluent written and verbal communication skills
7. High band in project management, communication, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team collaboration

Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.

Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.