A contract manufacturer of medical devices urgently needed to fill a critical gap left by the resignation of its VP of RA/QA. Complicating the situation: The manufacturer was addressing an FDA Form 483 that required weekly progress reports on the mitigation plan. With the help of ELIQUENT (formerly Oriel STAT A MATRIX), the company was able to access the senior-level RA/QA expertise it needed to maintain compliance while the search for a permanent candidate was conducted.
Customer Challenge
The unexpected resignation of the company’s VP of RA/QA left this critical role open while there was an outstanding FDA Form 483 – and no internal candidate available to fill the role
The role of VP of RA/QA is not a position that can remain vacant – but it takes time to recruit and hire the right candidate. The company turned to ELIQUENT to fill the gap during its search for a full-time candidate.
ELIQUENT Approach
Provide an interim VP of RA/QA to manage compliance activities and keep the FDA 483 mitigation plan on track while the company recruited a replacement for the position
ELIQUENT offers access to a deep pool of qualified regulatory and quality assurance professionals who average 25 or more years of international and domestic life sciences industry experience.
ELIQUENT clarified the customer’s needs and identified an Executive Management Consultant to act as Interim VP for RA/QA. The selected professional had the required process engineering, process improvement, and manufacturing operations expertise; was capable of interfacing with the FDA district office; and was based near the manufacturer’s site.
Results
The company was able to take the time it needed to find the right person to fill the permanent VP of RA/QA position without compromising compliance
The ELIQUENT consultant did more than fill the gap left by the previous VP of RA/QA’s resignation. During the engagement, the Interim VP of RA/QA also:
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Performed daily hands-on QA/QC operations responsibilities.
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Trained new employees in QA roles.
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Oversaw multiple successful OEM client audits.
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Helped institute operating process improvements.
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Established a CAPA system.
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Kept the 483 mitigation plan on track and provided technical inputs for the company attorney’s weekly letter to FDA.
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Assisted in interviewing and on-boarding the permanent hire.