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 and product changes, monitoring and responding to regulatory changes, preparing for and facilitating inspections, managing 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: Manage the LNH QMS change management process (e.g., monitor proposed and executed changes to regulations and standards, evaluate major changes to processes and/or infrastructure that may impact the QMS, etc.) and drive formal activities within LNH to respond to those changes. Evaluate 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 provide approval or required feedback for next courses of action. Review document change orders (DCOs) for approval and provide feedback and guidance to LNH personnel on generating compliant documents and records of change. Leadership: Provide oversight to assigned Quality Systems team members by supervising, guiding, and directing employees to be effective team members. Ensure that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Use 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. Ensure project/department milestones and goals are met and achieved while staying within approved budgets. Quality Management System: Manage escalated issues arising from QMS related activities throughout the organization and ensure coordination with key stakeholders from other departments for sustainable corrective actions. Manage, monitor, and analyze the development of quality standards, protocols and procedures using prescribed KPIs. Create and/or manage, as applicable, dashboards for key QMS activities and serve as an SME for modules/forms of the eQMS under the team’s purview. Compliance & Lean: Ensure organizational compliance and facilitate 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. Host third party audits onsite or virtually as directed by senior leadership. Facilitate inspections by external sources (such as FDA, ISO, AATB, state agencies, alliance partners, etc.) and ensure follow up actions are completed. Drive Lean initiatives with the QS department and ensure 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 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 steam mapping, 5S, Kaizen events) Quality Auditor Certification – American Society for Quality Certified Quality Auditor (CQA) Lean 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, determine relevance to processes within the organization, and ensure 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

WHY JOIN LIFENET HEALTH

When you join LifeNet Health, you’re not just taking a job, you’re joining a mission‑driven community dedicated to making a global impact through regenerative medicine. You’ll be part of a workplace that values authenticity, collaboration, and the drive to make a difference. We recognize that great work happens when people feel supported. That’s why our total rewards package is designed to help you thrive both professionally and personally. Here’s how we support YOU: Affordable Medical, Dental, and Vision Coverage - Comprehensive care that won’t break the bank. Profit Sharing Plan - Share in the success you help create. 403(b) Retirement Plan - Invest in your future with confidence. Paid Parental Leave - 6 weeks to bond with your newest family member. Corporate Sponsored Events - Celebrate milestones and build connections. Generous Paid Time Off - Because balance matters: 18 vacation days (based on position, tenure, and state laws) 9 sick days (subject to local and state regulations) 9 holidays (7 standard + 2 floating) Flexible Work Program - For approved roles, how and where you perform best. Tuition reimbursement - We invest in your growth and education. Career & Leadership Development - Expand your impact and potential. Wellness Program - Prioritize your health with holistic resources. Employee Assistance Program (EAP) - Support for you and your household. Incredible teammates - Collaborate with passionate, dedicated professionals. Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law. This job posting does not constitute an employment contract and does not alter the “at‑will” nature of employment at LifeNet Health.

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. As part of our commitment to safety, we maintain a drug‑free workplace and conduct pre‑employment substance abuse screening.

COMPENSATION

Salary Range: $87,226 - $116,301 annually Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience. Actual compensation may be higher based on the successful candidate’s knowledge and relevant experience. #J-18808-Ljbffr American Society for Quality