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Manager, Quality Assurance

Employer
Labcorp
Location
Maidenhead, United Kingdom
Salary
Competitive
Start date
16 Oct 2020
Closing date
15 Nov 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


The Manager, Quality Assurance can work home or office based anywhere within the EU.

Manage and support Clinical QA needs of assigned clients and their respective clinical trial programs.

Plan, manage and conduct monthly QA to QA meetings with assigned client QA contacts.

Develop, manage and maintain Quality Agreements for assigned clients.

Provide GCP support and consultation to internal Covance project teams.

Attend study team meetings for Clinical QA input as needed.

Provide Inspection Readiness support to Covance teams and respective clients.

Provide Inspection Management support for Covance and client inspections including overseeing development of inspection responses, QC review of responses, client communications, preparing daily summaries, managing inspection mailbox & tracker, and Inspection follow-up.

Support the Client Interactions group for client audits including onsite client audit support when necessary.

Participation in Joint Operating Committee meetings.

#LI-NC1
Education/Qualifications:
Minimum Requirements

 

  • University or College Degree (BA/BS, life science preferred) or equivalent experience;
  • Must have a wealth of direct GCP QA experience in a CRO or sponsor quality organization;
  • Must have strong working knowledge and application of GCP, ICH GCP and local regulations;
  • Must have strong interpersonal and communication skills and the ability to effectively work with QA representatives of Covance clients who maybe be of equal or higher level;
  • Must have working knowledge of CAPA and CAPA processes;
  • Must have ability to travel up to 20%;
  • Prior experience in supporting client audits and regulatory inspections.

Experience:

 

  • University or College Degree (BA/BS, life science preferred) or equivalent experience;
  • Must have a wealth of direct GCP QA experience in a CRO or sponsor quality organization;
  • Must have strong working knowledge and application of GCP, ICH GCP and local regulations;
  • Must have strong interpersonal and communication skills and the ability to effectively work with QA representatives of Covance clients who maybe be of equal or higher level;
  • Must have working knowledge of CAPA and CAPA processes.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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