Associate Director, Clinical Quality
3 weeks ago
Our client is a leading Global Biopharma with a Clinical Trial Centre of Excellence based in Dublin City Centre. They play a crucial role in developing life-saving therapies as they strive to cure unmet medical needs. They are global leaders in the development of therapies in the areas of Infectious Diseases, Oncology & Inflammation.
They are looking for an experienced Associate Director with extensive GCP auditing experience to join their Clinical Quality Business Partner team who is ready to dive-in to support their therapeutic areas and clinical development programs. In this role you will represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk. The full title of the role is:Associate Director, Clinical Quality Business Partner, Therapeutic Area Support.
This role is suited to candidates who possess expert Good Clinical Practice (GCP) knowledge, strong project management and communication skills, strategic thinking ability and proven success in a matrixed organization.
As part of Global R&D Quality & Medical Governance you will be joining a supportive team that fosters constructive collaboration in support of our clinical development programs promoting a culture of quality.
Role/Responsibilities:
BA or BS and 10+ years of relevant experience (8+ years of relevant experience with an applicable MS). At least 6 years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-pharma sponsor experience 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 10% required.
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