The Sr. IT Program Manager will oversee IT projects to improve quality and compliance in the CDMO sector, manage budgets, vendor relations, and ensure regulatory adherence.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Top Skills
Erp
Lims
Mes
Qms
Scm
Thermo Fisher Scientific Waltham, Massachusetts, USA Office
168 Third Avenue, Waltham, MA, United States
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