Ref #: 27903

Employment type: Permanent - Full-Time

Location: US-NC-Raleigh

Posted: 12-Mar-2021


As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them? At ICON DOCS, we have an incredible opportunity for expert CAPA Managers to join the team in the US. Multiple positions available for home-based CAPA Managers throughout the US.

This position will support the Global Development organization and its Investigation Owners in the CAPA development and implementation process as a direct result of audits, inspections and self-identified issues for both in-house and outsourced trials with a regional/global scope. The CAPA Manager will oversee the Nonconformance/CAPA process and serve as the CAPA process expert for investigation owners through nonconformance identification, investigation, execution and resolution.

What you need:
• BS/BA Degree is required or
• A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GXP experience within clinical research and development and/or quality assurance.
• Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis is required
• Knowledge of the overall drug development process
• Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
• Act as process and system SME for the nonconformance and CAPA process and business/system requirements

Why join us?
Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
Ongoing development is vital to us, and as a Clinical Trial Manager, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.