Christopher Arnold
Marietta
Summary
Dynamic Senior Global Compliance Manager with Thermo Fisher Scientific, driving a 20% expansion in compliance services. Expert in regulatory compliance and policy development, leveraging strong organizational leadership to enhance quality systems. Proven track record in stakeholder engagement and risk management, delivering impactful solutions in high-stakes environments.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Senior Global Compliance Manager
Thermo Fisher Scientific
01.2021 - Current
- Advancing the Compliance Service Program (IQ/OQ/PQ, PM, Calibration of Laboratory Equipment) to a global level by providing effective Quality, Commercial and Operational leadership. Revenue Growth peaking at $35.6M.
- Key influencer within the organization by Interacting with the global organization at all levels to implement “best practice” strategies and scalable solutions.
- Routinely hosted live webinars for high growth areas. Providing consultation to Pharma, Biotech, Cell & Gene Therapy and other key life Science organizations on compliance via an effective risk management approach.
- Developed policies and procedures to govern all aspects of the business from protocols, tools to employee training, mentoring and certification.
- Compliance Service portfolio expanded by 20% from 2023 to 2024.
Senior Quality Manager, North America
Thermo Fisher Scientific
01.2013 - 01.2021
- Sr Quality Manager and Management Representative of 5 sites across North America with over 1500 employees to ISO 9001:2015, 13485 and FDA Quality System Regulation 820.
- Implemented new software systems and tools to transform our quality program to higher levels. MasterControl, Document Management, CAPA, Deviations, Change Management, KPI dashboarding, Audit, Complaints, Risk Management, Record Management and Employee training program.
- In full partnership with local, cross divisional and corporate leadership teams to establish and complete strategic quality initiatives and enhancements for Medical Device readiness.
- Provided guidance to the IT Software Development teams to ensure controls are built into the standard workflow, resulting in improved compliance, productivity and reliable products on a consistent basis.
- Utilized PPI tools, Gemba Walks and lean techniques with to streamline our business to drive organizational and process efficiency.
- Organizational Leadership by providing routine communications, meetings, and events to bolster “Right First Time with the customer in mind” mentality, resulting improved customer allegiance and PPI involvement.
Qualification Services Manager
Thermo Fisher Scientific
01.2009 - 01.2013
- Provided leadership and direction to 30+ Field Service Engineers on a national level, ranging from training, business strategy, capital equipment investments, business operations, customer priority and workload forecasts.
- IQOQPQ subject matter expert on wireless systems, cold chain management, warehouse, Ln2 & Cryo storage, incubators, biosafety, water purification and beyond.
Global Product Manager, Lab Equipment
Thermo Fisher Scientific
01.2007 - 01.2009
- Portfolio Management - New Product Development (NPD) – Utilizing the stage-gate process, drive development of new services and Sales Support of “Value Add” Services.
- Product launch of the “Smart-Vue” wireless monitoring solution. A wireless product designed to monitor lab equipment within a regulated environment. SME on Compliance to 21cfr part 11.
- Project leader to develop the divisions first online e-parts store – www.labequipmentparts.com. Project included method to promote key sale overstock items and deployment of multiple sales champagnes.
Service Product Specialist
Thermo Fisher Scientific
01.2003 - 01.2007
- Lab Equipment Technical Product expert and liaison between the OEM Manufacturing sites and the field service organization.
- Development and implementation of related training program.
Supervisor Application Engineer
Johnson Controls
01.2000 - 01.2003
- Development of Building Management and HVAC Control Systems (HVAC / Monitoring systems).
- System qualification provided to major pharmaceutical customers – Pfizer, Eli Lilly, Amgen.
Education
Bachelor’s Degree - Technical Management
DeVry University
Columbus, OhioISO 9001-2015 Lead Auditor -
Skills
- Organizational leadership
- Regulatory compliance and oversight
- Policy development and implementation
- Audit management and internal auditing
- Data analysis and process improvement
- Change management and control
- Effective communication skills
- Team leadership and collaboration
- Stakeholder engagement and influencing
- Project management and execution
- Cross-functional collaboration strategies
- Risk assessment and mitigation
- Investigative skills and document reviews
- Training development and coordination
- Performance evaluation methodologies
- Document control and retention practices
- Quality management systems (GLP/GMP, ISO9001:2015, 13485, 17025)
- Cold chain management solutions (CTL temperature mapping, wireless monitoring)
Recognition And Achievements
- 12/31/18, Member of the Thermo Fisher Corporate Quality Council
- 12/31/17, Involvement achievement award received from the Corporate Quality QARA team
- 12/31/14, Nominee - Corporate Quality Award for extraordinary achievement and organizational contribution
- 12/31/13, Thermo Fisher Scientifics’ Developing Emerging Leaders (DEL) program
Accomplishments
Recognition & Achievement Awards
· 2018 - Member of the Thermo Fisher Corporate Quality Council
· 2017 - “Involvement” achievement award received from the Corporate Quality QARA team
· 2014 - Nominee - Corporate Quality Award for extraordinary achievement and organizational contribution
· 2013 - Thermo Fisher Scientifics’ Developing Emerging Leaders (DEL) program
Certification
- ISO 9001-2015 Lead Auditor
Timeline
Senior Global Compliance Manager
Thermo Fisher Scientific
01.2021 - Current
Senior Quality Manager, North America
Thermo Fisher Scientific
01.2013 - 01.2021
Qualification Services Manager
Thermo Fisher Scientific
01.2009 - 01.2013
Global Product Manager, Lab Equipment
Thermo Fisher Scientific
01.2007 - 01.2009
Service Product Specialist
Thermo Fisher Scientific
01.2003 - 01.2007
Supervisor Application Engineer
Johnson Controls
01.2000 - 01.2003
Bachelor’s Degree - Technical Management
DeVry University
ISO 9001-2015 Lead Auditor -
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