Manager, Quality & Compliance

Why Renovo?

Renovo Solutions is a nationwide healthcare and life sciences technology management company. We offer a range of opportunities for employees to grow within the company. With a presence in 40+ states and a growing international footprint, we provide comprehensive solutions for managing and maintaining the equipment our clients depend on. We prioritize investing in our employees’ development, offering various phases and advancement paths.

Through ongoing training, mentorship programs, and a supportive work environment, we foster professional growth and promote from within. Join our team to make a difference while advancing your career with Renovo.

Summary:

The Manager, Quality and Compliance owns the compliance position of the Enterprise Laboratory Instrument Services (ELIS) program across North America. This is a compliance role first. The core of the job is making sure the people doing the work are trained and qualified to do it, the vendors performing work are qualified to perform it, and the records produced will stand up to a client audit or a regulatory inspection.

A large share of the instrument estate on this program is GxP critical. Every scheduled maintenance, calibration and repair on those assets produces a record that has to meet good documentation practice, has to show the current version of the procedure was followed, and has to show that whoever performed the work and whatever standards they used were qualified at the time.

Where that chain breaks, it becomes a deviation, and deviations are handled here.

What you will do:

Training and qualification compliance, the core of the role:

Monitor training assignments and due dates for every Renovo person on the program, covering both Renovo-assigned and client-assigned training.

Confirm each person holds the correct training matrix for their role, site and asset scope, and that the matrix reflects what they actually work on.

Coordinate with the client and with individuals to keep training current, and accelerate before a due date passes rather than after.

Confirm nobody performs work on a GxP critical asset without current qualification, and hold that line under schedule pressure.

Maintain the qualification evidence in a form that can be produced on demand during an inspection.

Work with the Technical Training Specialist on curriculum content and delivery, and with the site supervisors on qualification sign-off.

Requalify vendors on the cycle the client procedures require.

Confirm vendor personnel hold the certification and training to perform the planned work, through compliance checks on a representative sample on a regular basis.

Confirm pre-approved vendor maintenance checklists and protocols are loaded into the system of record before the work is scheduled.

Withhold or suspend vendor work where qualification evidence is missing, and elevate rather than allow it to proceed.

Confirm good documentation practice is upheld and that the current version of the procedure was used for execution.

Review the qualification status of instruments and standards used by Renovo and by third parties during work on GxP critical assets, before the work rather than after.

Review GxP comments in the system of record and follow up where a standard procedure could not be followed.

Correct documentation issues before close out rather than accepting a defective record.

Coach the team on closing work orders correctly, and treat repeat defects as a training or process problem rather than correcting them repeatedly.

Coordinate non-conformances and out-of-specification events with the relevant client department or site, and agree next steps.

Lead quality investigations and establish cause rather than closing on symptom.

Own corrective and preventive action management through to effectiveness, not only to closure.

Track deviation volume and cause pattern, and act on what it shows.

Support the client through inspection and audit response with traceable evidence.

Own the periodic services…