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 YOULL MAKE AN IMPACT
As a Manager, Quality Systems Compliance and Change Management youll play a vital role in advancing our mission. In this position, youll 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 YOULL 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 teams 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 KPIs. Creates and/or manages, as applicable, dashboards for key QMS activities and serves as an SME for modules/forms of the eQMS under the teams 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 YOULL BRING
Minimum Requirements:

• Bachelors 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:

• Bachelors 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, youre joining a mission-driven community dedicated to making a global impact through regenerative medicine. Youll 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. Thats why our total rewards package is designed to help you thrive both professionally and personally.

Heres how we support YOU:

• Affordable Medical, Dental, and Vision Coverage- Comprehensive care that wont 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.

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 candidates knowledge and relevant experience.

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.