TrackWise QMS Specialist

Описание

We are looking for a high-performance TrackWise QMS Specialist to join a global Contract Development and Manufacturing Organization (CDMO) supporting pharmaceutical and biotech companies across the full drug lifecycle. Their capabilities span drug substance and drug product development, manufacturing of small-molecule APIs (including highly potent and controlled substances), and analytical and IND-enabling services. They partner with clients across North America and Europe to bring high-quality, compliant therapies to market. 

You will be part of a Quality Systems / IT Quality team, working closely with Quality Assurance, Manufacturing, Validation, and IT stakeholders. The role requires regular collaboration with both technical and non-technical users and offers visibility across multiple functions within a global organization. 

Experience / Skills required: 

Must have: 

Experience supporting QMS systems within pharmaceutical, biotech, or CDMO environments  3–5+ years of hands-on experience administering and supporting TrackWise QMS (Enterprise / on-prem) in a regulated environment  Strong working knowledge of cGMP, CSV principles, and GAMP 5  Experience ensuring system compliance with 21 CFR Part 11 and data integrity requirements  Proven ability to troubleshoot complex system issues and support business users effectively  Excellent communication, documentation, and problem-solving skills, with the ability to work across Quality, IT, and business teams  Upper-Intermediate English and better 

Good to have: 

Experience with Topdesk or similar ITSM / ticketing platforms  Exposure to TrackWise system upgrades, migrations, or integrations  Experience supporting audits and regulatory inspections from a quality systems perspective 

Responsibilities: 

Own the administration and ongoing support of the TrackWise QMS, including configuration, workflow management, and user access control  Act as a primary point of contact for QMS system issues, troubleshooting incidents and ensuring timely resolution for business users  Manage and track system support cases using Topdesk (or similar ticketing tools), documenting resolutions and best practices  Ensure the TrackWise system remains compliant with regulatory and quality standards, including 21 CFR Part 11, cGMP, and internal quality policies  Support system validation activities across the full lifecycle, including IQ, OQ, and PQ, and participate in functional testing  Develop, maintain, and improve system documentation, SOPs, and knowledge base articles to support audit readiness and user enablement  Collaborate with cross-functional teams on requirements gathering, system enhancements, upgrades, and go-live activities 

We offer:  

Competitive salary with the regular review  Vacation (up to 20 working days)  Paid sick leaves (10 working days)  National Holidays as paid time off  Flexible working schedule, remote format Direct cooperation with the customer  Dynamic environment with low level of bureaucracy and great team spirit  Challenging projects in diverse business domains and a variety of tech stacks  Communication with Top/Senior level specialists to strengthen your hard skills  Online teambuildings