Manager, Quality Systems Compliance and Change Management (10108-2026456)

About the role

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. This job is located in Virginia Beach, VA (Sabre) within the Quality Systems department. The schedule is Monday-Friday from 8:15 AM to 5:15 PM, and the clinical status is Enhanced Clinical.

Responsibilities

• Manages the LNH QMS change management process, including monitoring proposed and executed changes to regulations and standards, evaluating major changes to processes and/or infrastructure, and driving formal activities within LNH to respond to those changes.
• Evaluates process/product changes proposed by personnel throughout the organization to ensure regulatory compliance, providing 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.
• Leverages leadership skills to provide oversight to assigned Quality Systems team members, ensuring they are equipped with the right skills, tools, and talents necessary for executing their duties.
• Ensures that project/department milestones and goals are met and achieved while staying within approved budgets.
• Manages escalated issues arising from QMS related activities throughout the organization and ensures coordination with key stakeholders for sustainable corrective actions.
• Manages, monitors, and analyzes the development of quality standards, protocols, and procedures using prescribed KPI's, creating and/or managing dashboards for key QMS activities, and serving as an SME for modules/forms of the eQMS under the team’s purview.
• 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 and ensures follow-up actions are completed.
• Drives Lean initiatives with the QS department and ensures activities are formally captured and evaluated for effectiveness.

Requirements

• Bachelor’s Degree in a relevant field (Business, Healthcare Management, Engineering, Biological Sciences, or Allied Health)
• 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
• THREE (3) Years – Supervisory/management experience with direct reports

Preferred Experience/Skills/Certifications

• Bachelor’s Degree – Business, Healthcare Management, Engineering, Biological Sciences, or Allied Health field
• TWO (2) Years – Experience with Lean manufacturing concepts & tools (Value stream mapping, 5S, Kaizen events)
• Quality Auditor Certification – American Society for Quality Certified Quality Auditor (CQA)
• Ledan Certification – Six Sigma Green Belt or Black Belt
• Change Management Certification – Certified Change Management Professional (CCMP)

Key Knowledge, Skills, & Abilities

• Industry regulations, standards, and guidelines – Experience reviewing requirements, determining relevance to processes within the organization, and ensuring compliance as applicable
• People Development – Actively engages in talent management practices (selection, promotion, development, and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs
• Analytical Thinking – Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
• Problem Resolution – Experience to anticipate and critically think through problems
• Technical Writing – Able to create and revise procedures, technical documents, and other relevant material according to established requirements
• Microsoft Office – Proficient in Microsoft Office
• Engineering – Understanding of basic engineering concepts

Benefits

• Affordable Medical, Dental, and Vision Coverage
• Profit Sharing Plan
• 403(b) Retirement Plan
• Paid Parental Leave
• Corporate Sponsored Events
• Generous Paid Time Off
• Flexible Work Program
• Tuition Reimbursement
• Career & Leadership Development
• Wellness Program
• Employee Assistance Program (EAP)

Compensation

Salary Range: $87,226 - $116,301/annually

Equal Opportunity Employer

LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.