Job Title: QMS Process Lead / SME (TrackWise Digital)
Location: Remote (EST/CT preferred)
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:
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.
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.
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.
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:
- 5+ years of 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 (e.g., CBAP, PMP) are a plus.
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Note: Not a pure testing role. Must have experience beyond CSV
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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