Quality Assurance and Compliance Manager (Ottawa or Toronto)
Allphase Clinical Research Inc. - Ottawa, ON

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Duties:

  • Conducts contracted audits; provides high quality, detailed, and professional auditing services
  • Communicates audit findings clearly both verbally and in writing
  • Experience in developing Quality Management Systems
  • Assists in the management of patient support programs
  • For all assigned projects, reviews sponsor contract proposals, protocols, CRFs and other relevant study documents and interacts with project team members to develop a thorough and unambiguous understanding of all tasks required
  • Audits clinical protocols, Trial Master Files, clinical investigator sites, clinical databases, study reports, and other areas as needed
  • Reviews and authors Allphase’s internal quality assurance SOPs
  • May act as a reviewer for other Allphase SOPs
  • Manages and maintains the Allphase QMS
  • Conducts internal & external audits of functional departments (process audits); accesses compliance with applicable SOPs and relevant regulatory requirements
  • Is thoroughly familiar with, and follows all applicable Allphase and client SOPs; documents clearly any deviations from these SOP; contributes to Allphase’s continuous improvement efforts
  • Attends regional and functional group meetings as required
  • May participate in investigator’s meetings as required
  • Interacts with clients and participates in client meetings as necessary
  • Prepares estimates for QA Services to be included in Request for Proposals (RFPs)
  • Fulfills other assignments which are consistent with the scope of responsibilities of a Quality Assurance Auditor
  • Assists in marketing of auditing/compliance services to potential clients
  • Serves as a resource for other employees
  • Demonstrates good analytical and organization abilities, dedication to quality and reliability in all work tasks
  • Responds to client needs and a focus on client satisfaction; genuine commitment to team work

Qualifications:

  • Nursing degree or degree in life science or a related field, or certification in a related allied health profession from an appropriately accredited institution
  • Thorough knowledge of applicable clinical research regulations (FDA, HFPB, EMA, etc) and ICH guidelines
  • Thorough understanding of research and development processes for pharmaceutical products and/or medical devices required
  • Experience in a variety of audit types (investigator site, process/systems, vendor, document, due diligence audits, etc.)
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
  • Minimum 2 years GCP auditing experience required
  • Must be able to travel up to 60% of the time
  • Excellent English and French communication skills (verbal and written).

Indeed - 18 months ago - save job
About this company
Allphase Clinical Research is a progressive Contract Research Organization (CRO) dedicated to providing quality and service excellence to...