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Quality Management Systems Manager
2 months ago
Function: Advisory
Area of Interest: Quality Management Systems
Description:
KPMG's Advisory practice is experiencing rapid growth, driven by increasing client demand. Our professionals are required to be flexible and excel in a collaborative, team-oriented environment. At KPMG, our employees are our top priority. We offer extensive learning and career development opportunities, a premier training facility, and leading market tools to ensure continuous professional and personal growth. If you seek a firm that fosters strong team connections and allows you to be your authentic self while making a significant impact, advancing your skills, and exploring new areas of inspiration, consider a career in our Advisory practice.
KPMG is currently seeking a Manager specializing 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 clients in the Life Sciences sector.
- Manage the implementation of Quality Systems projects by developing comprehensive user, functional, and technical requirements, along with 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; offer guidance on developing effective technology solutions that enhance 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 necessary.
- 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 the applicant's skills, job responsibilities, prior relevant experience, specific degrees and certifications, and market considerations. Additionally, KPMG provides a comprehensive benefits package designed to support your health and well-being, including various medical and dental plans, vision coverage, disability and life insurance, 401(k) plans, and a suite of personal well-being benefits. Details about our benefits can be found on the KPMG US Careers site.
KPMG is an affirmative action-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 applicable laws.
