IT Project Manager – GMP Applications (SEEQ & Statistica Upgrade)
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking an experienced IT Project Manager with deep GxP and validation expertise to lead the upgrade of SEEQ and Statistica - critical GMP-compliant analytics tools used in manufacturing and process environments. The role requires strong coordination across IT QA process engineering vendors and data teams.
Key Responsibilities:
- Lead GMP application upgrades (SEEQ & Statistica) with full validation lifecycle (CSV/CSA)
- Coordinate vendor delivery ensuring compliance with validation cybersecurity and documentation standards
- Drive cross-functional collaboration across QA Process Owners Digital/Data and IT Compliance
- Develop and manage validation plans testing traceability risk assessments and release documentation
- Maintain RAID logs lead risk workshops and manage change control and cutover plans
- Ensure strict adherence to 21 CFR Part 11 Annex 11 and ALCOA principles
- Manage multi-site/staged deployments in a regulated manufacturing setting
Qualifications :
Required Skills & Experience:
- Solid experience with GxP-regulated software upgrades or implementations
- Hands-on CSV/CSA knowledge and validation strategy execution
- Familiarity with SEEQ OSIsoft PI or similar time-series analytics platforms (TrendMiner etc.)
- Experience with Statistica JMP Minitab or other statistical tools
- Understanding of data integrations with PI MES LIMS and file-based systems
- Strong stakeholder & vendor management across diverse functions
- Excellent communication governance and presentation skills (e.g. Steering Committee readiness)
Preferred Qualifications:
- Experience with global/multi-site pharma deployments
- Background in manufacturing analytics or process systems in GMP environments
- Comfortable navigating complex compliance and regulatory frameworks
Additional Information :
At Fusion we aspire to be one of the worlds leading life sciences consulting firms setting industry benchmarks with innovative and pioneering solutions.
At Fusion we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.
Hiring Philosophy: We value employees who push boundaries through innovation navigating diverse client needs in ever-evolving environments with a commitment to continuous learning both for themselves and their colleagues.
Growth & Development: Go beyond grow beyond and maximize impact. Each employee shapes their own journey and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections extended learning motivation and support to experiment with new and innovative approaches including taking risks.
Feedback Culture: We emphasize and promote continuous real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift and inspiring individuals is our competitive advantage!
Shape you own journey - How far will you take yourself
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- IT Experience
- Project Management Methodology
- Project / Program Management
- IT Project Management
- Agile
- PMBOK
- Visio
- Waterfall
- Project Management
- Microsoft Project
- Project Management Lifecycle
- SDLC
About Company
Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.With over 450 em ... View more
