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 escalate 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.

Vendor qualification and compliance:

• Qualify new vendors against client and Renovo quality compliance requirements before they perform work.
• 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 escalate rather than allow it to proceed.

Work order and documentation review:

• Own the compliance review of completed scheduled maintenance, calibration and repair records.
• 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.

Deviation management:

• Own non-conformance handling, including cases where GxP requirements were not met during maintenance, calibration or repair.
• 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.

Audit and inspection readiness:

• Prepare the Renovo team for client and regulatory inspections and audits.
• Support the client through inspection and audit response with traceable evidence.
• Own the periodic services quality review across all GxP activity performed by the team.
• Close audit findings and observations to a defined date, and confirm the fix held.
• Maintain readiness continuously rather than assembling it ahead of a scheduled audit.

Processes, documentation and continuous improvement:

• Confirm all Renovo processes on the program are documented and that the documentation matches current practice.
• Maintain process flows for the processes in use.
• Support optimisation of existing processes, and confirm any change is reflected in the documentation and the training before it goes live.
• Provide training and retraining on Renovo and client processes to coordinators, engineers and analysts.
• Represent quality at regional and site operating meetings.

Leading the function:

• Lead the Quality and Compliance Specialists, including work allocation, development and performance management.
• Set the compliance standard across all North American sites so it does not vary by location.
• Act as the single point of contact for ELIS quality compliance in North America.
• Report compliance status, deviation position and training currency to the Regional Director of Operations and to client governance.

Escort and vendor hosting when on site:

• Escort is a standing expectation of every role on this program. When present at a client site, escort and host OEM and third-party personnel on request, regardless of whose scope the instrument sits in.
• Confirm third-party personnel are inducted, badged, and compliant with client site access and safety requirements before they enter a laboratory.
• Confirm the work performed matches what was authorised and the service record is complete before the third party leaves site.
• Escalate immediately where a third party arrives unannounced or attempts work outside the authorised scope.

Qualifications:

• 5+ years of experience in quality, compliance or regulatory affairs in a GxP environment.
• 2+ years of experience leading or managing a compliance function or team.
• Demonstrated ownership of a deviation, non-conformance and CAPA process end to end.
• Demonstrated experience monitoring training and qualification compliance across a distributed population.
• Experience qualifying and requalifying third-party service vendors against a client quality system.
• Experience supporting client audits and regulatory inspections, and closing findings.
• Working knowledge of good documentation practice, data integrity expectations, and GMP, GLP and GCP scope differences.
• Experience with a computerized maintenance management system (CMMS) as a compliance record system.
• Experience in a pharmaceutical, biotechnology or research environment required.

Education/Special Training:

• Bachelor’s degree in a scientific, technical or quality discipline preferred. Equivalent experience considered.
• Formal quality or compliance certification preferred, and supported where not already held.
• Training in GxP, data integrity, good documentation practice and client site safety provided or required.
• CMMS and platform training provided after hire.

Required Competencies:

• Compliance Backbone - holds the qualification and documentation line under schedule and commercial pressure.
• Root Cause Discipline - closes an investigation on cause, not on symptom.
• Preventive Mindset - treats a repeat defect as a training or process failure rather than a record to correct again.
• Audit Readiness - maintains evidence continuously rather than assembling it before a scheduled audit.
• People Leadership - develops the compliance team and the wider program, not only inspects it.
• Practicality - knows the difference between a real compliance risk and a paperwork preference.
• Communication - explains a compliance requirement to an engineer in terms they can act on, and a compliance position to client governance.
• Integrity - can admit mistakes, is direct and truthful, and acts in the best interest of clients, employees and Renovo.

Success Measures:

• KPI 3 attainment. KPI 3 is the only measure in the client agreement that sits outside the annual deduction cap, at $500,000 per product-related corrective and preventive action miss with no annual ceiling stated.
• Training currency across the program, measured as assignments completed by due date
• Personnel performing GxP work without current qualification, target zero
• Vendor qualification and requalification current, with no unqualified vendor work performed
• Vendor compliance sample checks completed on cycle
• Documentation defects corrected before close out rather than after
• Repeat documentation defects addressed at source
• Deviation and non-conformance cycle time, and closure on cause
• CAPA effectiveness confirmed, not only closed
• Audit and inspection findings, and findings closed to date
• Periodic services quality review completed on cycle
• Process documentation current against actual practice
• Compliance standard consistent across all North American sites

Safety Requirements:

• Abide by and follow Renovo safety policies, procedures, and injury and illness prevention expectations.
• Maintain a safe working environment for self and others when visiting customer sites, laboratories, offices, or operational environments.
• Follow applicable customer site safety requirements, OSHA guidelines, and laboratory or facility-specific procedures as required.
• Complete required safety training assignments on time.

Physical Requirements:

• Predominantly remote, office-based work.
• When on assigned client sites, presence in active laboratory environments including areas with biological, chemical, electrical and cryogenic hazards.
• Ability to wear required personal protective equipment when on site.
• Travel approximately 20 to 30 percent, covering assigned sites for compliance review, audit support, training coordination and client governance.

Classification:

FLSA: Exempt

Note: This position description does not list every activity, duty, and responsibility of the position and may be altered by RENOVO at any time.

EEO Statement

RENOVO Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, RENOVO Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Employee is an at-will employee, and this does not act as a contract of employment.