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Posted 3 months ago
Requirements and responsibilities
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.
Optionally, you can add more information later (benefits, pre-screening questions, etc.)