Barden are delighted to be supporting our client, a renowned biotechnology company that specializes in the research, development, and commercialization of innovative therapies in the field of life sciences in their search for an Associate Director GCP Quality & Compliance.
ABOUT THE ROLE:
- Represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk.
- Serve as Clinical Quality Business Partner lead for assigned clinical trial programs.
- Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
- Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Lead or Assist in readiness preparation, and/or directly support regulatory agency inspection.
- Lead deviation identification, reporting, and CAPA development.
- Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
ABOUT THE PERSON:
- BA or BS and 10+ years of relevant experience (8+ years of relevant experience with an applicable MS).
- 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.
Please get in touch with Aidan Crowley in Barden (firstname.lastname@example.org) to discuss further.
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