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What happens when your VP of RA/QA leaves on short notice?
Oriel STAT A MATRIX to the rescue!

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 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 Oriel STAT A MATRIX to fill the gap during its search for a full-time candidate.

Oriel STAT A MATRIX 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

Oriel STAT A MATRIX 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.

Oriel STAT A MATRIX 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 Oriel STAT A MATRIX 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:

  • Performed daily hands-on QA/QC operations responsibilities.
  • Trained new employees in QA roles.
  • Oversaw multiple successful OEM client audits.
  • Helped institute operating process improvements.
  • Established a CAPA system.
  • Kept the 483 mitigation plan on track and provided technical inputs for the company attorney’s weekly letter to FDA.
  • Assisted in interviewing and on-boarding the permanent hire.
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