Reference Number: JO-2107-473396
Senior GCP Quality Assurance Manager
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.
- 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.
- 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.