GCP Auditing Manager - Contract - Remote, USA
Champion audit excellence and quality assurance to advance safe, compliant, and successful clinical studies.
Proclinical is seeking a Manager, GCP Auditing to support quality assurance activities within the pharmaceutical industry. This position offers the opportunity to work remotely within the USA, with occasional travel required.
Primary Responsibilities:
The successful candidate will focus on implementing risk-based quality auditing processes and ensuring compliance with Good Clinical Practice (GCP) standards and international regulations.
Skills & Requirements: GCP Auditing's
- Strong communication skills with the ability to collaborate effectively across various organizational levels and externally.
- Proven ability to take initiative, work independently, and demonstrate leadership.
- Bachelor's degree in a relevant field.
- Industry experience in quality assurance, with direct GCP auditing expertise.
- Familiarity with FDA and EU regulations, as well as ICH guidance documents.
- Willingness to travel domestically and internationally (30-40%).
The GCP Auditing Manager's responsibilities will be:
- Manage the end-to-end audit process, including scheduling, preparation, execution, reporting, and follow-up for routine and directed audits.
- Conduct internal and external audits globally, covering investigator sites, service providers, and internal processes.
- Represent the quality assurance team on complex compliance projects and cross-functional initiatives.
- Develop and implement risk-based audit programs for clinical studies.
- Interpret policies, standards, and regulations, addressing critical compliance issues as needed.
- Participate in regulatory inspections, supporting control or inspection room activities.
- Assist in training, orientation, and mentoring of new quality assurance staff.
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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