Quality Management Systems Manager

1 week ago


Charlotte, North Carolina, United States KPMG-UnitedStates Full time
Business Title: Manager, Trackwise Digital Architect - QMS
Function: Advisory
Area of Interest: Life Sciences Solutions
Description:

KPMG's Advisory practice is experiencing significant growth, driven by increasing client demand. Our professionals are expected to be flexible and excel in a collaborative environment. At KPMG, we prioritize our employees, offering extensive learning and career development opportunities, along with a world-class training facility and advanced market tools. If you seek a workplace that fosters team connection and allows you to grow both personally and professionally, consider a career in our Advisory practice.

We are currently looking for a Manager in Life Sciences Solutions within our Consulting practice.

Key Responsibilities:

  • Oversee Quality Systems and Digital Transformation initiatives, including QMS IT strategy, vendor selection, configuration, change management, and implementation for various quality processes such as complaints management, CAPA, change control, audits, and supplier quality for Life Sciences clients.
  • Manage the implementation of Quality Systems projects by developing comprehensive user, functional, and technical requirements, as well as design and configuration specifications, data migration strategies, integrations, testing, and validation.
  • Identify potential quality challenges for clients and business development opportunities; provide insights into regulatory trends and expectations; guide the development of effective technology solutions that deliver business value.
  • Support client relationship development, identify opportunities, assist with proposals, and contribute to pricing strategy development.
  • Lead fast-paced client engagements across multiple functional domains, ensuring timely and quality delivery of work products; monitor project status, issues, and risks, and present summary information to clients and executive sponsors as required.
  • Represent KPMG's thought leadership in Digital Transformation within Quality Management at conferences, publications, and other forums related to our practice offerings.

Qualifications:

  • A minimum of five years of relevant experience in Quality Systems within the pharmaceutical, biotech, or medical device industries.
  • A Bachelor's degree from an accredited institution in a relevant field is required; a Master's degree is preferred.
  • Experience in configuring and implementing TrackWise Digital - Quality Management System for the Life Sciences sector across one or more TrackWise Digital modules such as Platform, EQMS, Complaints, SQM, etc.
  • TrackWise Digital Certification and Salesforce Certification (Admin/Platform App Builder/Platform Developer) are required.
  • Prior experience in developing functional/configuration specifications, data migration strategies, and validation (IQ/OQ/PQ) test scripts for implementing TrackWise Digital application functionalities.
  • Experience integrating TrackWise Digital with other enterprise systems (SAP, CRM, RIM, DMS, TMS, Data Warehouse, etc.) is essential.
  • Applicants must be authorized to work in the United States without the need for visa sponsorship now or in the future.

KPMG adheres to all local and state regulations regarding salary range disclosures. The offered salary is determined based on relevant factors such as skills, job responsibilities, prior experience, degrees, certifications, and market considerations. KPMG offers a comprehensive benefits package designed to support your well-being, including medical and dental plans, vision coverage, disability and life insurance, 401(k) plans, and various personal well-being benefits. Personal Time Off is provided annually, along with observed holidays and firmwide breaks throughout the year.

KPMG is an equal opportunity employer and complies with all applicable federal, state, and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by law.



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