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.

About the role

The Manager, Quality and Compliance owns the compliance position of the Enterprise Laboratory Instrument Services (ELIS) program across North America. This is a compliance‑first role focused on ensuring that personnel, vendors, and records meet client audit and regulatory inspection standards, especially for GxP‑critical assets.

Responsibilities

• Training and qualification compliance: Monitor training assignments and due dates for all Renovo personnel on the program; confirm correct training matrices; coordinate with clients and individuals to keep training current; prevent unqualified work on GxP‑critical assets; maintain qualification evidence for inspection.
• Vendor qualification and compliance: Qualify new vendors against client and Renovo requirements; re‑qualify vendors on required cycles; verify vendor personnel certifications; ensure pre‑approved checklists are loaded before work; withhold or suspend work lacking qualification evidence.
• Work order and documentation review: Review completed maintenance, calibration, and repair records for good documentation practice; verify use of current procedures; assess qualification status of instruments and standards before work; correct documentation issues before close‑out; coach the team on proper work order closure.
• Deviation management: Own non‑conformance handling for GxP deviations; coordinate with client departments; lead quality investigations to root cause; manage corrective and preventive actions through effectiveness; track deviation volume and patterns.
• Audit and inspection readiness: Prepare the Renovo team for client and regulatory inspections; support audit responses with traceable evidence; conduct periodic quality reviews of all GxP activity; close audit findings by defined dates and verify fixes.
• Processes, documentation, and continuous improvement: Ensure all Renovo processes are documented and aligned with practice; maintain process flows; support process optimization and update documentation/training accordingly; provide training to coordinators, engineers, and analysts; represent quality at regional and site meetings.
• Leadership: Lead Quality and Compliance Specialists, handling work allocation, development, and performance management; set consistent compliance standards across North American sites; act as single point of contact for ELIS quality compliance; report status to Regional Director of Operations and client governance.
• Escort and vendor hosting when on site: Escort and host OEM/third‑party personnel; ensure they are inducted, badged, and compliant with site access and safety requirements; verify authorized work and complete service records before departure; escalate unannounced or out‑of‑scope work immediately.

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 deviation, non‑conformance, and CAPA processes end‑to‑end.
• Experience monitoring training and qualification compliance across a distributed population.
• Experience qualifying and re‑qualifying 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, GCP scope differences.
• Experience with a computerized maintenance management system (CMMS) as a compliance record system.
• Background in Pharmaceutical, Biotechnology, or Research environments.

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 if 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 – maintains qualification and documentation under schedule and commercial pressure.
• Root Cause Discipline – closes investigations on cause, not symptom.
• Preventive Mindset – treats repeat defects as training or process failures.
• Audit Readiness – maintains evidence continuously.
• People Leadership – develops the compliance team and broader program.
• Practicality – distinguishes real compliance risk from paperwork preference.
• Communication – translates compliance requirements for engineers and client governance.
• Integrity – admits mistakes, acts truthfully, and prioritizes client, employee, and Renovo interests.

Success Measures

• KPI 3 attainment (financial impact of missed corrective/preventive actions).
• Training currency across the program (assignments completed by due date).
• Zero personnel performing GxP work without current qualification.
• Vendor qualification and re‑qualification current; no unqualified vendor work performed.
• Vendor compliance sample checks completed on cycle.
• Documentation defects corrected before close‑out.
• Repeat documentation defects addressed at source.
• Deviation and non‑conformance cycle time; closure on cause.
• CAPA effectiveness confirmed, not merely closed.
• Audit and inspection 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 Renovo safety policies, procedures, and injury/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 facility‑specific procedures. Complete required safety training assignments on time.

Physical Requirements

Predominantly remote, office‑based work. When on client sites, presence in active laboratory environments with biological, chemical, electrical, and cryogenic hazards. Ability to wear required personal protective equipment on site.

Travel

Approximately 20–30 % travel to assigned sites for compliance review, audit support, training coordination, and client governance.

Classification

FLSA: Exempt.