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Senior Regulatory Compliance – Trackwise Consultant
EYTrackWise Consultant responsible for implementing TrackWise Digital Quality Management systems for Life Sciences clients. Collaborating with teams to ensure compliance and high-quality deliverables in regulated environments.
About the role
Key responsibilities & impact- As a TrackWise Consultant, you will be responsible for delivering end-to-end TrackWise Digital implementations, from requirements gathering and solution design through configuration and testing.
- You will work closely with client business, IT, and quality stakeholders to translate business needs into compliant system solutions.
- The role involves developing GxP documentation, supporting validation activities (IQ/OQ/PQ), conducting system demos, and ensuring high-quality delivery aligned with regulatory and quality standards.
- You will also contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes.
Requirements
What you’ll need- Bachelor’s degree in computer science, Electrical/Electronic Engineering, Information Technology, or a related field (or equivalent)
- Minimum of 5+ years of relevant experience as a TrackWise / Quality Systems Consultant.
- Experience working in GxP‑regulated Life Sciences environments with exposure to quality systems
- Knowledge of global drug safety regulations including FDA, EMA, ICH guidelines.
- Detail-oriented with excellent data entry and organizational skills.
- Ability to work independently and as part of a team in a fast-paced, regulated environment.
- Strong communication skills to interact effectively with internal teams and external stakeholders.
- Proficiency for dashboard and PV related analytical reports creation using Power BI and similar tools.
- Willingness to work flexible hours or shifts if required.
- Hands‑on experience configuring and implementing TrackWise Digital – Quality Management System in the Life Sciences industry
- Experience implementing one or more TrackWise Digital modules such as Platform, EQMS, Complaints, SQM.
- Experience with Change Control module (preferred within must‑have scope)
- Experience developing GxP documentation such as functional/configuration specifications and test scripts (IQ/OQ/PQ)
- Experience integrating TrackWise Digital with enterprise systems (SAP, CRM, Data Warehouse, etc.).
- Strong understanding of quality systems and validation lifecycle for regulated applications.
- Proven experience supporting project execution, including coordination across business, IT, and quality stakeholders.
- Strong analytical and problem-solving skills to identify and resolve data discrepancies.
- Commitment to maintaining patient safety and data confidentiality.
- Excellent time management skills to meet strict reporting deadlines.
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
TrackWise DigitalGxP documentationvalidation activitiesPower BIanalytical reportsChange Control modulefunctional specificationsconfiguration specificationstest scriptsintegration with enterprise systems
Soft Skills
detail-orientedorganizational skillsindependent workteam collaborationstrong communicationanalytical skillsproblem-solving skillstime managementcommitment to patient safetydata confidentiality