Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO).
Argument Development & Case Creation
- Collaborate with business leaders to determine opportunities where technology provides measurable business value.
- Develop and present cases justifying investments by outlining the value, benefits, and resource requirements.
- Translate strategic goals into actionable IT roadmaps that support growth, scalability, and regulatory compliance.
- Support portfolio governance and prioritization discussions through data-driven analysis.
Financial Oversight
- Manage program budgets, forecasts, and capital/operating expense planning.
- Monitor and report financial performance, ensuring accountability and transparency.
- Identify cost optimization and efficiency opportunities within vendor and system portfolios.
- Provide variance analysis and investment recommendations to senior leadership.
Vendor & Partner Management
- Lead the selection, contracting, and performance oversight of technology vendors and service providers.
- Negotiate statements of work (SOWs) and service-level agreements (SLAs) in collaboration with Procurement and Legal.
- Monitor vendor delivery, quality, and compliance performance against expectations.
- Champion positive relationships that drive innovation and operational excellence.
Quality, Compliance & Inspection Readiness
- Ensure all IT programs meet global regulatory and validation standards (21 CFR Part 11, GxP, GAMP 5, EU Annex 11).
- Maintain ongoing inspection readiness by ensuring complete validation documentation and traceability.
- Partner with Quality and Compliance teams to prepare for internal and external audits.
- Represent IT during inspections and drive timely remediation where vital.
Systems & Integration
- Manage the incorporation and enhancement of essential platforms like ERP, MES, QMS, LIMS, and SCM systems.
- Ensure system development aligns with data integrity, cybersecurity, and infrastructure standards.
- Collaborate with architects and functional leaders to enable process harmonization and scalability.
Experience
- 5+ years of proven experience leading IT projects within the life sciences, biotech, or pharmaceutical manufacturing industry (Preference for CDMO experience).
- Demonstrated success leading large, complex, cross-functional technology initiatives.
- Strong understanding of Quality, Regulatory, and Supply Chain business procedures.
- Experience developing and leading program budgets and justifications.
- Proven success leading vendors and third-party service providers.
- Practical familiarity with ERP, MES, QMS, LIMS, or Supply Chain systems.
- Solid understanding of GxP and data integrity requirements.
- Strong leadership, influencing, and collaboration skills.
- Excellent communication and presentation abilities with executive audiences.
- Ability to lead multiple initiatives in a fast-paced, regulated environment.
- Certifications such as PMP, ITIL, or Agile Scrum Master preferred.
