Michael Page Logo

Main menu

  • Home
  • Jobs+

    Browse for Jobs

    • https://www.michaelpage.com.hk/
    • Banking & Financial Services
    • Construction
    • Digital
    • Education
    • Engineering & Manufacturing
    • Finance & Accounting
    • Healthcare
    • Human Resources
    • Legal
    • Life Sciences
    • Marketing
    • Procurement & Supply Chain
    • Retail & Sourcing
    • Property
    • Sales
    • Secretarial & Business Support
    • Technology
    • Executive Search

    Searching for a job?

    • Submit your CV
    • Submit your CV
    • Resume and cover letter advice
    • Salary guide
    • Salary comparison tool

    Contracting

    • Contracting
    • Benefits of Contracting
    • FAQs for Contractors
    • View Contracting Jobs

    Looking to return to Hong Kong?

    • https://www.michaelpage.com.hk/
    • Returning to HK

    Quick Job Search

  • Contracting
  • Recruiting+

    Recruitment Expertise

    • https://www.michaelpage.com.hk/
    • Banking and Financial Services
    • Construction
    • Digital
    • Engineering and Manufacturing
    • Education
    • Finance and Accounting
    • Healthcare
    • Human Resources
    • Legal
    • Life Sciences
    • Marketing
    • Procurement and Supply Chain
    • Property
    • Retail and Sourcing
    • Sales
    • Secretarial and Office Support
    • Technology
    • Executive Search

    Looking to hire?

    • Recruitment services
    • Recruitment services
    • Outsourcing / project recruitment
    • Job Advertising: ReachTalent

    Hiring Contractors

    • Hiring Contractors
    • Benefits
    • FAQs

    Start a Hiring Conversation

    • Request a call back
    • Request a call back

    Salary & Hiring Insights

    • Salary guide
    • Salary guide
    • Salary benchmarking tool
    • Hiring advice
    • AI hiring trends & report
    • Blockchain hiring trends & report
  • Advice+

    Career Advice

    • Career Advice
    • Career progression
    • Changing jobs
    • Interview
    • Productivity and performance
    • Resume and cover letter
    • Salary and negotiation
    • Work-life balance

    Powering Asia's Future

    • https://www.michaelpage.com.hk/
    • Stories from 9 inspirational leaders in Asia

    Transformational Leadership

    • Eight Executive Trends for 2020
    • Eight Executive Trends for 2020

    Management advice

    • Management advice
    • Engagement and retention
    • Hiring
    • Leadership
    • Staff development
    • Diversity and inclusion

    Market insights

    • Market insights
    • Market updates
    • Industry reports
    • Salary Guide 2021
    • Market Movers

    Leading Women

    • https://www.michaelpage.com.hk/
    • Women in Leadership Interviews

    Popular articles

    • Best practices for virtual recruitment and hiring
    • Top 10 highest paying jobs in Hong Kong for 2021
    • AI Innovations & Hiring Trends
    • How to negotiate for a higher salary in 2020
    • Common interview questions
    • Resume and cover letter
    • How to manage a remote team effectively
    • 8 must have qualities of an effective leader
  • About+

    About us

    • Who we are
    • Recruitment services
    • Diversity & inclusion
    • Media releases
    • Awards
    • Reviews
  • Join PageGroup+

    Join PageGroup

    • Work for us
    • Why choose us?
    • Your role here
    • Use your skills
    • FAQs
    • Apply now
  • Contact+

    Contact us

    • Find our office
    • Find our office
    • Looking to hire?
    • Submit your CV
    • Feedback
  • 企业招聘+

    企业招聘

    • https://www.michaelpage.com.hk/
    • 咨询服务
    • 中资企业新浪潮
Sign In
Saved jobs (0)
Saved jobs (0)
Sign In
Login or Sign up
Search for a job
Back to search

Clinical QA Manager/Director

Shànghǎi
Permanent
  • Apply
  • share this job
  • Email Job
  • Save Job

Bullet points

  • This company is about to launch Pre- IPO and provide stock option to employees

  • a promising platform to develop career with support of a very decent team

About Our Client

Company one is a cell therapy company that is about to launch Pre- IPO abroad China with 5 first-in-class products, one of which launches the clinical trials in China/US/Canada. It will build up a manufacturing facility in North Carolina.

Company two is a oncology-immunology biopharma with 2 star products which separately got the clinical trial approval by CFDA in 2016 and is engaged in the R&D pharmacological toxicology, launching the IND in both US and China in the near future.

Job Description

Develop, maintain, and oversee GCP quality management process including internal SOP for clinical development activities

Develop Study Quality Oversight Plan for sponsored clinical trials and conducts quality oversight visits of clinical trial sites, contract research organizations (CRO) and suppliers.

Develop (or work with QA vendor) on QA plan and conduct audits of clinical trial sites, suppliers, protocols, and study reports and report all audit observations to clinical sites and management.

Conducts system and process audits as required, e.g. pharmacovigilance, data management, safety and clinical operations etc.

Maintains GCP regulatory compliance and quality performance.

Responsible for communicating quality issues to internal stakeholder, including resource requirements to maintain QA compliance.

Prevent and mitigate quality risks that can jeopardize interests (patient safety, supply continuity, reputation).

Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to clinical sites and management

Drive a continuous improvement / on-going development mind-set together with clinical operations team and management

Manage Quality metrics and key process indicators reporting through monthly quality reporting

Execute quality compliance activities: SOP approval, deviation documentation and CAPA

Establish and execute GCP training programs

Establish audit program for sponsored clinical trials

Host local regulatory and health authority inspections

The Successful Applicant

Bachelor degree or above with 3-8 years work experience ans 1-2 years management experience.

Familiar with GCP compliance and quality Assurance.

Proven track record in multinational company or middle level biopharma.

What's on Offer

Fast promotion opportunity.

Abundant project experience.

Competitive salary

Contact:
Daisy Lian
Quote job ref: 4148349
+8621 6035 3432
Save Job
Apply
Clinical QA Manager/Director

Job summary

Function:Life Sciences
Specialisation:Clinical Operations
Industry:Healthcare / Pharmaceutical
Location:Shànghǎi
Contract Type:Permanent
Consultant name:Daisy Lian
Consultant phone:+8621 6035 3432
Job Reference:4148349

Similar Jobs

Manufacturing Science Director(Small molecule)
Save Job
Permanent
HK$73,093 - HK$109,640
View Job
Purification Senior Director/Executive Director
Save Job
Permanent
View Job
Quality Senior Manager
Save Job
Permanent
View Job
  •  
  • 1 of 3
  • Show more jobs
Manufacturing Science Director(Small molecule)
Save Job
Permanent
HK$73,093 - HK$109,640
View Job
Purification Senior Director/Executive Director
Save Job
Permanent
View Job
Quality Senior Manager
Save Job
Permanent
View Job
Medical Lab Technologist - Leading Biotech Company
Save Job
Permanent
View Job
Tech Transfer Associate Director (Large Molecule)
Save Job
Permanent
HK$137,050 - HK$137,141
View Job
Oncolytic Virus R&D Director/Executive Director
Save Job
Permanent
View Job
Analytical development Director
Save Job
Permanent
View Job
Senior Medical Technologist/ Lab Director
Save Job
Permanent
View Job
IVD Clinical Application Manager
Save Job
Permanent
View Job
View More Jobs

Sign up to receive job alerts

We will let you know when any new !keyword jobs are available. | We will let you know when any new !keyword jobs in !location are available. | Create an account to enable features like one click apply, and set up more than 5 job alerts
Michael Page Logo
  • Read our BlogRead our Blog
  • Follow us on FacebookFollow us on Facebook
  • Follow us on LinkedInFollow us on LinkedIn
  • Watch us on YouTubeWatch us on YouTube

General

  • Change Country/Region
  • Page Personnel Hong Kong
  • Page Executive
  • Investor site
  • PageGroup corporate site
  • Email Disclaimer
  • Site map
  • Site terms
  • Privacy policy

Jobs by function

  • Banking & Financial Services
  • Construction
  • Digital
  • Education
  • Engineering & Manufacturing
  • Executive Search
  • Finance & Accounting
  • Healthcare
  • Human Resources
  • IT
  • Legal
  • Life Sciences
  • Marketing
  • Procurement & Supply Chain
  • Property
  • Retail & Sourcing
  • Sales
  • Secretarial & Business Support

Contact

  • Feedback
  • Looking to hire?
  • Submit your CV
 

Our Offices

  • Central Tower

Accreditations

ISO27001 Accreditation

Michael Page International (Hong Kong) Limited 米高蒲志國際(香港)有限公司 (Company No.176887, EA Licence No.60630 and its related brands – Page Executive (EA Licence No.58961), Page Personnel (EA Licence No.58960) and Page Outsourcing (EA Licence No. 58962) is part of the PageGroup. Registered Office: 17th Floor, Central Tower, 28 Queen’s Road Central, Central, Hong Kong