IT Project Manager – GMP Applications (SEEQ & Statistica Upgrade)

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

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

At Fusion, we aspire to be one of the world's 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?

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 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.

Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.

Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality.