Senior QMS Analyst, Track Wise Digital

The Senior Quality Management Systems (QMS) Analyst will play a key role in managing and supporting Curias TrackWise Digital platform, which serves as the enterprise Quality Management System (QMS) and Document Management System (DMS). TrackWise Digital is a managed application on the SalesForce Cloud.
This role requires a strong understanding of quality system processes - including Change Control, Deviations, CAPA, Complaints, Audits, and Document Control - combined with technical expertise in TrackWise Digital configuration, workflow management, integrations, and validation.

The ideal candidate will bridge business needs and technical capabilities, ensuring that Curia’s global quality operations are efficiently supported, compliant with GMP regulations, and aligned with enterprise system governance standards.

This is a role for an experienced professional with demonstrated initiative and ownership. Candidates who may not meet all requirements should demonstrate the ability to learn quickly, proactively seek knowledge, and deliver measurable value through innovation and continuous improvement.

Key Responsibilities

**System Administration & Support**

• Serve as the primary system administrator for Track Wise Digital (QMS and DMS), overseeing configuration, user access, roles, and security.
• Provide production support for day-to-day operations, including issue resolution, workflow troubleshooting, and coordination with vendor support.
• Support release patches, regression testing, upgrades, and environment validation.

**Process & Configuration Management**

• Configure and enhance modules such as Change Control, CAPA, Deviations, Complaints, and Document Management in Track Wise Digital.
• Partner with business stakeholders to gather and analyze requirements, define solutions, and validate system changes.
• Implement approved configuration changes, test scripts, and validation documentation per GXP and CSV (Computer System Validation) standards.

**Enhancement & Project Work**

• Work on minor enhancements (under 80 hours) directly; for larger enhancements, coordinate scoping and written estimates with IT management before execution.
• Support integrations between Track Wise Digital and other enterprise applications such as Oracle ERP, SAP, and LIMS.
• Collaborate with QA and IT validation teams to ensure compliant and timely deployment of enhancements.

**Compliance & Documentation**

• Ensure ongoing compliance with GMP, FDA, and ISO 9001/13485 quality system requirements.
• Maintain up-to-date validation documentation, user access reviews, and change control records.
• Participate in audits and regulatory inspections, providing system information and documentation as needed.

**Collaboration & Governance**

• Partner closely with Corporate Quality, IT Compliance, and Enterprise Applications teams to ensure alignment with Curia’s governance and data integrity principles.
• Contribute to the development and enforcement of global standards for TrackWise Digital configuration, usage, and documentation.

Qualifications

• Education

• Bachelor’s degree in computer science, Life Sciences, Quality Management, or related field.

• Experience

• 5+ years of experience supporting a QMS/DMS application like TrackWise Digital (preferred) in a GMP or regulated environment.
• Strong understanding of quality management processes (Change Control, CAPA, Deviations, Complaints, Audits, Document Control).
• Hands-on experience with system configuration, testing, and validation documentation.
• Familiarity with integration concepts between QMS/DMS and ERP, LIMS, or CRM systems.
• Knowledge of CSV, 21 CFR Part 11, and GxP requirements.

• Technical Skills

• TrackWise Digital configuration and administration
• Workflow design and form configuration
• Data extraction/reporting (e.g., TWD Analytics, SQL basics)
• Validation and documentation management

• Soft Skills

• Strong analytical, communication, and problem-solving skills
• Ability to work independently and manage multiple priorities
• Proven initiative, ownership mindset, and commitment to quality and compliance

• Additional Notes

• This position is part of the Enterprise Applications team. It will collaborate with other analysts supporting Oracle ERP, SAP, Salesforce, and other enterprise systems to ensure end-to-end process continuity.
• Candidates must be detail-oriented, quality-driven, and able to thrive in a dynamic, global, cross-functional environment.