Manager, Quality Assurance

Employer
Covance
Location
Maidenhead, , United Kingdom
Salary
Competitive
Closing date
16 Oct 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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Job Overview:
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.

Covance Profile Page image

Join our growing team and discover your extraordinary potential


We are recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, our comprehensive service portfolio provides the opportunity to explore diverse projects and unique career paths across the drug development spectrum.

Please visit our Careers Hub

Learn more about our work to improve health and improve lives:

https://youtu.be/Wx2wxyLd7no

Contact Us
  • Maidenhead Office Park
  • Westacott Way
  • Maidenhead
  • SL6 3QH
  • United Kingdom
  • Mini-site: Covance
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