Manager, Quality Systems Compliance and Change Management

LifeNet Health•Virginia Beach, VA

6d•$87,226 - $116,301•Onsite

About The Position

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.

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
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

Nice To Haves

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)

Responsibilities

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.
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.
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.
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.