Manager, Trackwise Digital Architect - QMS

About the position

The Manager, Trackwise Digital Architect - QMS at KPMG is responsible for leading Quality Systems and Digital Transformation projects within the Life Sciences sector. This role involves managing the implementation of Quality Management Systems (QMS), ensuring compliance with regulatory standards, and driving business value through effective technology solutions. The position requires collaboration with clients to develop user requirements, manage project timelines, and represent KPMG's thought leadership in Digital Transformation at various forums.

Responsibilities

• Lead Quality Systems related and Digital Transformation projects including QMS IT strategy, Vendor Selection, Configuration, Change Management, Implementation for various Quality processes such as Complaints Management, CAPA, Change Control, Audits, Supplier Quality, etc. for Life Sciences clients
• Manage Quality System implementation projects by developing detailed user requirements, functional requirements and technical requirements, design & configuring specifications, data migration approach, integrations, testing and validation
• Identify potential quality issues at clients and business development targets; provide insights into the trends and expectations of regulatory agencies; deliver guidance on developing effective technology solutions that drives business value
• Support client relationship development efforts, identify opportunities, assist with proposals and contribute to the development of the pricing strategies
• Run fast paced client engagements across multiple functional domains for on-time and quality delivery of work products; track project status, issues, and risks as well as present summary information to clients and executive sponsors as needed
• Represent KPMG Thought leadership in the area of Digital Transformation in Quality Management at conferences, in publications, and other forums as it relates to practice offerings

Requirements

• Minimum five years of recent work experience related to Quality Systems within the pharmaceutical, Biotech and/or medical device industry
• Bachelor's degree from an accredited college/university in an appropriate field required; Master's degree from an accredited college/university preferred
• Experience configuring and implementing TrackWise Digital - Quality Management System for the Life Sciences industry in one or more TrackWise Digital modules
• TrackWise Digital Certified and Salesforce Certified (Admin/Platform App Builder/Platform Developer)
• Prior experience with developing Functional/Configuration specifications, Data migration strategy and validation (IQ/OQ/PQ) test scripts for implementing TrackWise Digital application functionality
• Experience integrating TrackWise Digital with other enterprise systems (SAP, CRM, RIM, DMS, TMS, Data Warehouse, etc.)
• Applicants must be currently authorized to work in the United States without the need for Visa sponsorship now or in the future

Benefits

• Life insurance
• 401(k) plans
• Medical and dental plans
• Vision coverage
• Disability insurance
• Personal Time Off per fiscal year
• Firmwide breaks during the year
• Robust suite of personal well-being benefits to support mental health