云顶新耀 · Development

QC Manager/Senior Manager

Salary negotiable  /  Working experience not required  /  Shanghai

2024-01-04 Update

The job requires you to fill in extra information

APPLYAFTERSCANE

因联合利华仅允许通过微信端网申
请注册/登录后直接点击“立即投递”扫码到微信端填写简历

Scan and start referral
with gift!

Referral

If you find this job has any violation, please report it.

Success

3 seconds to close

Report

Job Type

  • Recruitment Type:Social Recruitment
  • Work Type:Full-Time

Job descriptions

Position Summary:

职位概述:

 Perform quality control and inspection readiness activities to study delivered by Clinical Operations team

 Support continuous process optimization, training management in Clinical Operations

 Support site Inspection/Audit or Sponsor Inspection/Audit

Key Responsibilities

主要职责

 Partner with study team to ensure assigned studies meet mandatory compliance requirement and standards including ICH-GCP, SOP/guideline and regulatory requirement

 Partner with study team to drive site Inspection readiness and study QC activities

 Support study team to ensure gaps identified during QC activities are appropriately addressed

 Participate, support and actively contribute to continuous process improvements, knowledge management and training management

 Collaborate with QA and other stakeholders in Everstar to support site Inspection/Audit or Sponsor Inspection/Audit

Job qualifications

Recommended Education and Key Competency

建议的教育背景和主要能力

 Basic Qualifications

 Minimum Bachelor degree major in life sciences, preferably in medical, biology, pharmacology

 Minimum 5 years of clinical operations experience including 1 year of quality management relevant experience

 Preferred Qualifications

 Study management experience at country level

 Past experience with CFDI inspection

 Global pharmaceutical company and/or global CRO working experience

 Knowledge

 Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical studies

 Familiar with clinical drug development process

 Solid understanding of study conduct at China sites

 Key Competencies

 Quality driven and proven records of high quality standard

 Good communication and organization skills

 Critical thinking and problem solving

 Good cross-functional working ability

 Creative and innovative mindset, proactive working attitude

 Scientific/Technical excellence

 Ability to work effectively in a changing environment

 Language: Chinese&Business English fluency

Job requirements

  • Degree:Bachelor
  • Work Experience:Working experience not required
  • Language:Not Required