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Associate Director, Clinical Quality & Compliance, Dublin
Location: Dublin, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 52cd0c43140d
Job Views: 5
Posted: 01.06.2025
Expiry Date: 16.07.2025
Job Description:
Our client is a leading Global Biopharma with a Clinical Trial Centre of Excellence based in Dublin City Centre. They develop life-saving therapies aimed at curing unmet medical needs. They are global leaders in therapies for Infectious Diseases, Oncology & Inflammation.
They seek an experienced Associate Director with extensive GCP auditing experience to join their Clinical Quality Business Partner team, supporting therapeutic areas and clinical development programs. This role involves representing R&D Quality & Medical Governance on global clinical study teams, advising on GCP risk.
This position is suitable for candidates with expert GCP knowledge, strong project management and communication skills, strategic thinking, and success in a matrixed organization.
The team fosters collaboration and a culture of quality to support clinical development programs.
Role/Responsibilities:
* Serve as Clinical Quality Business Partner lead for assigned clinical trial programs, managing multiple projects.
* Perform global risk assessments for investigator site and vendor audit planning.
* Collaborate with the Audit, Inspection, and CAPA Management Team within R&D Quality & Medical Governance.
* Work with clinical study teams to ensure compliance, manage issues, and support improvements.
* Support regulatory inspections and coordinate responses to findings.
* Lead deviation reporting and CAPA development.
* Lead intra/inter-departmental teams supporting operations, including regulation evaluation.
* Review and evaluate SOPs and other procedures supporting the QMS.
* Promote a culture of quality within the organization.
* Oversee work of team members as needed.
Experience/Qualifications:
* BA or BS and 10+ years of relevant experience, or 8+ years with an MS.
* At least 6 years of audit and compliance experience, with significant GCP audit expertise.
* Bio-pharma sponsor experience preferred.
* Recognized expertise in clinical compliance topics.
* Strong communication and interpersonal skills.
* Proficient in Microsoft Office; experience with audit management/CAPA tools preferred.
* Excellent organization and project management skills.
* Ability to travel approximately 10%.
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