Job Description
Title: QMS Process Lead/SME
Position Summary: We are seeking a highly experienced QMS Business Process SME to play a critical role in a strategic initiative to modernize our Quality Management System. The ideal candidate will be an expert in NCEP (Non-Conformance Event Process), CAPAs, and Complaint handling processes. This individual will be responsible for leading the transition of these key quality processes from our legacy system to the new, state-of-the-art Trackwise Digital platform.
As the bridge between our business stakeholders and the technical implementation team, you will ensure that our future state is not just a copy of the old system, but a streamlined, efficient, and compliant process that leverages the full capabilities of the new platform.
Key Responsibilities: Process Analysis & Documentation: • Lead workshops and interviews with business stakeholders to capture, analyze, and meticulously document the "as-is" (current state) process requirements, workflows, and pain points for NCEP, CAPAs, and Complaints.
• Act with integrity, professionalism, and personal responsibility to uphold the firm's respectful and courteous work environment.
Future State Design: • Collaborate with cross-functional teams to design, optimize, and document the "to-be" (future state) processes, ensuring they align with industry best practices, regulatory requirements, and business objectives.
Requirements Translation: • Translate business needs into clear and concise functional requirements and user stories that the technical team can use to configure and develop the Trackwise Digital platform.
Stakeholder Alignment: • Act as the primary liaison between quality, regulatory, IT, and other business units to ensure alignment and build consensus on the future state design.
Solution Validation: • Review technical design documents and solution prototypes to ensure they accurately reflect the business requirements.
Testing and Validation Support: • Assist in developing test scripts, participate in User Acceptance Testing (UAT), and help triage defects to ensure the solution is fit for purpose.
Change Management & Training: • Support the development of new Standard Operating Procedures (SOPs), work instructions, and training materials to ensure a smooth transition for end-users.
Required Skills & Qualifications: • Minimum five years of recent experience as a Business Analyst or Subject Matter Expert within a Quality Management (QMS) function in a regulated industry (Medical Devices, Pharmaceuticals, or Life Sciences).
• Deep, demonstrable expertise in at least two of the following core QMS processes: Non-Conformance (NCEP), Corrective and Preventive Actions (CAPA), and Complaint Handling.
• Proven experience on at least one major system migration or implementation project, with a strong understanding of mapping "as-is" to "to-be" states.
• Exceptional analytical skills with the ability to deconstruct complex processes and identify opportunities for improvement.
• Excellent communication, facilitation, and documentation skills.
• NCEP, CAPS, Complaints, QMS, Trackwise Digital, Requirements Gathering, Current and Future State Process
Preferred Qualifications: • Direct, hands-on experience with Trackwise Digital is highly preferred.
• Experience with other enterprise QMS platforms (e.g., Veeva, MasterControl).
• Working knowledge of Computer System Validation (CSV) principles and practices.
• Experience in change management and business process re-engineering.
• Professional certifications in business analysis or project management (for example, CBAP, PMP) are a plus.
Note: 10% travel to Minnesota and Massachusetts
KPMG LLP ("KPMG") seeks a contractor in the United States to provide service to KPMG through one of our contracted employer/agency service providers. All applicants for any KPMG role are expected to act with integrity, professionalism, and personal responsibility to uphold the firm's respectful and courteous work environment. All applicants must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. KPMG LLP will not sponsor applicants for U.S. work visa status for this opportunity (no sponsorship is available for H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT or any other employment-based visa).
Nothing herein shall be deemed to create an employer-employee relationship between contractor and KPMG, nor shall contractor be considered a representative or agent of KPMG.
KPMG LLP and its subsidiaries comply with all local/state regulations in regard to displaying pay rate ranges. The pay rate range(s) displayed is/are specifically for those contracted who will perform work in or reside in the location(s) listed, if selected for the role. Pay is determined based on a variety of factors including market data, ranges, applicant's skills and prior relevant experience, certain degrees and certifications (e.g. JD, technology), and specific location, for example. Additionally, applicants may be required to apply and become employed by a service provider utilized by KPMG, and final pay rate(s) and/or eligibility for additional benefits may be determined by such provider.
KPMG LLP, its subsidiaries, and its agency service providers (including, but not limited to, MBO Partners Inc., Magnit LLC, and TalentBurst Inc.) are equal opportunity employers/contractors. All qualified applicants are considered without regard to race, color, creed, religion, age, sex/gender, national origin, ancestry, citizenship status, marital status, sexual orientation, gender identity or expression, disability, physical or mental handicap unrelated to ability, pregnancy, veteran status, unfavorable discharge from military service, genetic information, or other legally protected status.
Los Angeles County applicants: Material job duties for this position are listed above. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation. Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Job Tags
For contractors, H1b, Local area, Remote work