Quality Assurance Manager

Brook Street UK
08 Jul 2017
07 Aug 2017
Contract Type
Full Time
We are currently recruiting for a Quality Assurance Manager who will be responsible for quality assurance activities related clinical trials operations.
You will ensure accuracy, compliance and consistency of policies and procedures to local and regulatory agency laws and regulations participating in audits and inspections, tracking and trending metrics, and other appropriate quality control and quality assurance activities.
You will:-
" Develop and review global Quality policies and procedures.
" Provide quality review of company-wide policies and procedures.
" Ensure regulatory compliance for global clinical trials and laboratory operations
" Ensure global partner laboratories and other key vendors (reference laboratories, software vendors) are in compliance with applicable regulations, standards and policies and procedures.
" Participate in clinical trials client audits and regulatory inspections. Provide input to appropriate resolution of audit/inspection findings in a timely and effective manner.
" Manage quality issues, audit findings, complaints conducting a/or overseeing the conduct of, root cause investigations, development of corrective and preventive actions, and monitoring effectiveness.
" Lead and/or participate in interdepartmental audit activities.
" Review and/or approve validation plans and reports related to equipment, assay, and software.
" Track, trend and analyze internal Quality metrics
" Maintain a current understanding of regulatory trends and changes in regulations, guidance, including country or region specific, requirements and standards, evaluate the impact and advise appropriate management regarding issues affecting their operations. Disseminate information to senior leadership as necessary.
" Participate in Lean/Six Sigma, process improvement efforts.
" Communicate with Sponsors, Sites and clinical trials personnel, laboratory staff, and regulatory agencies to demonstrate that the highest standards of quality and compliance are maintained.
" Provide Quality input on clinical trials client proposals and service / quality agreements.
" Contribute content and participate on internal committees and teams representing Quality
The salary for this role is £25000 with benefits including 25 days holiday, free car parking, pension scheme, BUPA Healthcare and life assurance.
For more information please call Vicky on (Apply online only)