Overview

Reference Number: JO-2107-473396
Senior GCP Quality Assurance Manager
Rate: Negotiable
Job Type: Permanent
Location: Dublin City Centre

Our client are a top 15 global BioPharma company with a strong pipeline of therapies. They have an opening in the QA and compliance department in within their new facilities based in Dublin.

Primary Responsibilities

  • Serve as Clinical Compliance Lead for assigned clinical trial programs in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
  • Leads development of audit strategy plan(s) and ensuring timely execution of plans for assigned projects/programs.
  • Provide training and oversight of contracts auditors.
  • Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
  • Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, escalates as appropriate, and support continuous improvement.
  • Support deviation identification, reporting, and CAPA development
  • Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
  • Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.

Qualifications

  • BA or BS and significant relevant experience
  • Must have at significant number of years GCP audit and compliance experience. Bio-pharma sponsor or CRO experience required.
  • Significant experience with peadiatricclinical trials strongly preferred.
  • Recognized as an expert resource on a range of clinical compliance topics.
  • Strong verbal and written communication skills and interpersonal skills.
  • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
  • Excellent organization skills and project management.
  • Able to work equally well as part of a team or independently
  • Ability to travel approximately 25% required.
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