JULIA EBRIGHT
Chester Springs,PA
Summary
Accomplished Professional with education and experience (15+ years) in all aspects of quality systems, program management, and process excellence. Strong leadership, interpersonal and influential skills, most notably, the ability to partner with leadership teams within a matrix environment to drive the business agenda and achieve results.
Overview
19
19
years of professional experience
Work History
Senior Principal: Business Quality
Convatec
01.2021 - Current
- Manage global team of managers/specialists in ownership of Change Controls, Documentation Control, Records, Training and the Quality PMO
- Ensure controls are in place for reporting and tracking of QMS metrics
- Own key metrics to assess trends as it relates to compliance/continuous improvement
- Led cross functional team through RFP process to evaluate current LMS (Cornerstone) against industry competition
- Successfully demonstrated factual business case to migrate systems, gain Executive approval and implement training program
- Oversee and manage NC/CAPA's and contribute subject matter expertise to multifunctional investigations
- Application and business owner for EDMS (Documentum), LMS (ComplianceWire) and respective Trackwise Module (Change Control)
- Drive culture change for process and program adoption through introduction of KPI's, metrics and building key leadership partnerships
Program Manager: New Ways of Working, Retail Investment Group
Vanguard
01.2020 - 01.2021
- Oversaw projects, resources, and budget in accordance with mission and goals of the organization and Lean Transformation Program
- Supported teams to launch deployment of lean and agile concepts enabling transformation within subdivisions to focus on process excellence and drive continuous improvement
- Led business planning team to secure funding for 21-million-dollar program through development of the human capital strategy and business support model for 2021 organizational changes
Manager, Health Care Compliance: Global Policies, Procedures & Training
Johnson & Johnson
01.2017 - 01.2019
- Led coordination of efforts to recommend practical and effective enterprisewide policy/training solutions aligned with risk assessments
- Workstream Leader for change management and communications during 'Cornerstone OnDemand' global LMS implementation
- Partnered with business leaders to strategize and lead deployment of annual requirements for US Medical Device and Cross Sector Canada (Pharma & Consumer)
- Partnered with Policy and Legal leadership teams to update content and ensure changes were accurately communicated prior to policy release
Quality Training Manager, US
Depuy Synthes (Company of J&J)
01.2013 - 01.2017
- Managed US training team overseeing budget and maximizing resources to distribute workload evenly and effectively to support Global Initiatives
- Acted as functional process owner for training, and ensured all standards, documentation and process changes adhered to applicable standards/regulations
- Oversaw all internal/external audit activity and represented as it pertained to Global and Local procedures
- (FDA, TUV, BSI)
- Presented monthly training metrics at Executive Management Review
- Led the US Business Project team and stakeholders during first J&J enterprise initiative to implement 'Cornerstone OnDemand' (SUMMIT), resulting in launch for >5000 users
- Appointed project lead for the global training organization to process map, streamline, and update training process to ensure accurate operation in new Document Management System (Adaptive)
Learning Business Partner Lead, Supply Chain
Depuy Synthes (Company of J&J)
01.2011 - 01.2013
- Identified as business lead to onboard and manage team while overseeing four locations during GRQP (Global Remediation Quality Plan)
- Responsible for all change orders in que, working against process lifecycle to release and deliver on time
- Conducted 'Needs Assessment' for all incoming projects to consult on learning strategy, and determine resources, impact, and timeline
- Acted as key project member to create and redesign use of SharePoint workflow tool for processing Change Orders
- Initiated process improvement projects to create training for all US manufacturing sites to manage competencies for: Qualified Operator, Internal Audit, and Patient Specific Plate
- Achieved Certification as a Qualified Trainer in following courses: New Hire Orientation: Focus on QA, QS Document Trainer, Getting Production to Flow
Quality Coordinator
Synthes
01.2009 - 01.2011
- Supported manufacturing plants for all needs as related to quality systems
Staffing Recruiter
Aerotek Incorporated
01.2008 - 01.2009
- Assessed talent and skill set of candidates to ensure accurate submission for client positions
Marketing Coordinator
Applied Controls Incorporated
01.2006 - 01.2008
- Supported conversion of a CRM database from Telemagic to TourDeForce
Education
B.S. - PSYCHOLOGY; BUSINESS
Virginia Tech
Blacksburg, VA01.2008
International Business Program -
University of Switzerland
01.2007
Skills
- Project Management
- Quality Systems
- Policy and Procedures
- Audit Support
- System Implementation
- User Acceptance Testing
- CAPA/Root Cause Analysis
- Team Leadership
- Change Management
- FDA Regulations
- Process Improvement
- Vendor Management
- Training & Development
- Instructor-Led Facilitation
- Health Care Compliance
- Stakeholder Management
- Learning Management Systems
- GMP/GDP
Hobbies and Interests
- Family
- Traveling
- Yoga
- Fitness Instruction
- Gardening
- Home Projects
- Reading
- Philadelphia Sports
- Beaches
Professional Development
- Internal Auditor Training | ISO9001:2015, ISO13485:2016 and 21 CFR Part 820 QSR
- PROSCI Certified Change Practitioner
- LUMA Human Centered Design Thinking
- Health Care Compliance Certification Program; Seton Hall University of Law | Newark, NJ
- American Society for Quality (ASQ)
- Selected: Preliminary Round Judge for the 'International Team Excellence Award' | Malvern, PA
- Understanding FDA's Medical Device: QSR
- Essential Skills for Managing Projects
- See It, Change It, Lean It, 'Qualified Instructor'
- Advanced Presentation Skills
- Avoiding Landmines in your FDA Records
Attributes
- Driven
- Leader
- Results-oriented
- Ambitious
- Self-Starter
- Detail-Oriented
- Enthusiastic
- High Energy
- Flexible
- Solution minded
Timeline
Senior Principal: Business Quality
Convatec
01.2021 - Current
Program Manager: New Ways of Working, Retail Investment Group
Vanguard
01.2020 - 01.2021
Manager, Health Care Compliance: Global Policies, Procedures & Training
Johnson & Johnson
01.2017 - 01.2019
Quality Training Manager, US
Depuy Synthes (Company of J&J)
01.2013 - 01.2017
Learning Business Partner Lead, Supply Chain
Depuy Synthes (Company of J&J)
01.2011 - 01.2013
Quality Coordinator
Synthes
01.2009 - 01.2011
Staffing Recruiter
Aerotek Incorporated
01.2008 - 01.2009
Marketing Coordinator
Applied Controls Incorporated
01.2006 - 01.2008
B.S. - PSYCHOLOGY; BUSINESS
Virginia Tech
International Business Program -
University of Switzerland