[Hiring] Manager, Quality & Compliance @Renovo Solutions

Role Description

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:
  • Monitor training assignments and due dates for every Renovo person on the program.
  • Confirm each person holds the correct training matrix for their role, site and asset scope.
  • Coordinate with the client and individuals to keep training current.
  • Confirm nobody performs work on a GxP critical asset without current qualification.
  • 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.
  • Collaborate with site supervisors on qualification sign-off.
• Vendor qualification and compliance:
  • Qualify new vendors against client and Renovo quality compliance requirements.
  • Requalify vendors on the cycle the client procedures require.
  • Confirm vendor personnel hold the certification and training to perform the planned work.
  • Confirm pre-approved vendor maintenance checklists and protocols are loaded into the system of record.
  • Withhold or suspend vendor work where qualification evidence is missing.
• Work order and documentation review:
  • Own the compliance review of completed scheduled maintenance, calibration and repair records.
  • Confirm good documentation practice is upheld.
  • Review the qualification status of instruments and standards used during work on GxP critical assets.
  • Review GxP comments in the system of record.
  • Correct documentation issues before close out.
  • Coach the team on closing work orders correctly.
• Deviation management:
  • Own non-conformance handling.
  • Coordinate non-conformances and out-of-specification events with the relevant client department.
  • Lead quality investigations and establish cause.
  • Own corrective and preventive action management through to effectiveness.
  • Track deviation volume and cause pattern.
• Audit and inspection readiness:
  • Prepare the Renovo team for client and regulatory inspections and audits.
  • Support the client through inspection and audit response.
  • Own the periodic services quality review across all GxP activity performed by the team.
  • Close audit findings and observations to a defined date.
  • Maintain readiness continuously.
• Processes, documentation and continuous improvement:
  • Confirm all Renovo processes on the program are documented.
  • Maintain process flows for the processes in use.
  • Support optimisation of existing processes.
  • Provide training and retraining on Renovo and client processes.
  • Represent quality at regional and site operating meetings.
• Leading the function:
  • Lead the Quality and Compliance Specialists.
  • Set the compliance standard across all North American sites.
  • 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.
• Escort and vendor hosting when on site:
  • Escort and host OEM and third-party personnel on request.
  • Confirm third-party personnel are inducted, badged, and compliant with client site access and safety requirements.
  • Confirm the work performed matches what was authorised.
  • Escalate immediately where a third party arrives unannounced.

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.
• Integrity - can admit mistakes, is direct and truthful, and acts in the best interest of clients, employees and Renovo.

Success Measures

• KPI 3 attainment.
• 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.
• 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.
• 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.