Manager, Quality Systems Compliance and Change Management

AT LIFENET HEALTH, YOU ARE THE ADVANTAGE

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Together, we are united by a mission greater than ourselves, a purpose rooted in healing.

ABOUT THIS JOB
Location: Virginia Beach, VA (Sabre)

Department: Quality Systems

Schedule: Monday-Friday (8:15AM – 5:15PM)

Clinical Status: Enhanced Clinical
 

HOW YOU’LL MAKE AN IMPACT
As a Manager, Quality Systems Compliance and Change Management you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for ensuring regulatory compliance and effective management of process and product change throughout the LifeNet Health organization. This position provides leadership and oversight for compliance and change management related activities throughout LNH, including: evaluation of process, product changes, monitoring/responds to regulatory changes, preparing for and facilitating inspections, management of QMS dashboards and Lean implementation.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

WHAT YOU’LL DO

• Change Management: Manages the LNH QMS change management process (e.g., monitoring proposed and executed changes to regulations and standards, evaluating major changes to processes and/or infrastructure that may impact the QMS, etc.) and drives formal activities within LNH to respond to those changes. Evaluates process/product changes proposed by personnel throughout the organization to ensure regulatory compliance (e.g., change control review, product development/launch activities, general idea proposal meetings, etc.) and provides approval or required feedback for next courses of action. Reviews document change orders (DCOs) for approval and provides feedback and guidance to LNH personnel on generating compliant documents and records of change.
• Leadership: Provides oversight to assigned Quality Systems team members by supervising, guiding, and directing employees to be effective team members. Ensures that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Uses the established people processes (performance, development, succession, and career) to ensure that their team’s level of performance and capabilities meet current and future standards. Ensures project/department milestones and goals are met and achieved while staying within approved budgets.
• Quality Management System: Manages escalated issues arising from QMS related activities throughout the organization and ensures coordination with key stakeholders from other departments for sustainable corrective actions. Manages, monitors, and analyzes the development of quality standards, protocols and procedures using prescribed KPI’s. Creates and/or manages, as applicable, dashboards for key QMS activities and serves as an SME for modules/forms of the eQMS under the team’s purview.
• Compliance & Lean: Ensures organizational compliance and facilitates inspections with Association for Advancing Tissue and Biologics (AATB) standards, FDA regulations, MDSAP and applicable state and international requirements through QMS training, Gemba walks, and zone assessment activities at LNH sites. Hosts third party audits onsite or virtually as directed by senior leadership. Facilitates inspections by external sources (such as FDA, ISO, AATB, state agencies, alliance partners, etc.) and ensures follow up actions are completed. Drives Lean initiatives with the QS department and ensures activities are formally captured and evaluated for effectiveness.

WHAT YOU’LL BRING
Minimum Requirements:

• Bachelor’s Degree
• FIVE (5) Years – Combined work experience related to quality management system (QMS) change management (minimum 2 years reviewing, approving and executing process/document changes) & compliance (minimum 2 years performing independent first- or second-party audits) in a tissue banking, pharma, or med device/FDA regulated environment