Covance

Quality Assurance Manager (Clinical Diagnostic)

Company
Covance
Location
Shardlow, United Kingdom
Salary
Competitive
Posted
30 Apr 2021
Closes
06 May 2021
Ref
10024_61733
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Covance by Labcorp is looking to hire a QA Manager, with Clinical Diagnostis experience to join our expending team in our new site in Shardlow.

The main responsabilities will be:

  • Manage ISO 15189 accredidation
  • Ensure appropriately trained resources are available, whilst providing guidance and consultation for the team, in order to make sure that tasks are completed according to procedural requirements
  • Ensure the consistent implementation, use and review of SOPs
  • Escalate issues to management in a timely manner, implementing appropriate solutions including preventative actions
  • Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
  • Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
  • Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
  • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
  • Interpret applicable quality regulations/standards and create appropriate policies and procedures
  • Lead interactions with clients or regulatory agencies
  • Recruit, train, coach and develop individuals based on their development or business needs
  • Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
  • Perform other duties, as assigned by management


Education/Qualifications:
  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Experience may be substituted for education.
Experience:
  • 5 to 8 years in regulatory environment (ISO 15189), with Clinical diagnostics experience
  • Experience & regulatory expertise of industry quality systems/standards
  • Ability to interpret applicable regulations/standards
  • Experience in leading process improvement initiatives
  • Ability to communicate and negotiate internal stakeholders effectively
  • Ability to supervise resources in a single geographic location