PROJECT MANAGER – LIFE SCIENCES (SYSTEMS & IT MANUFACTURING) @ INTELLECTT
The Project Manager for Life Sciences (Systems & IT Manufacturing) is responsible for leading the end-to-end delivery of complex systems and IT manufacturing projects within a highly regulated pharmaceutical and biotech environment. This role focuses on project planning, scheduling, execution, and governance to ensure all project milestones are met while strictly adhering to compliance standards and business objectives. You will be instrumental in defining project scope, managing resources, and implementing robust risk management strategies to ensure project success.
Candidates will coordinate extensively with cross-functional teams including Manufacturing, Quality Assurance, IT, Automation, and Validation. Key duties include financial tracking, budget management, and stakeholder communication to provide progress updates and leadership reviews. The role also requires overseeing change control processes and ensuring all technical documentation meets GxP, GMP, GAMP5, and 21 CFR Part 11 standards. This is an onsite position based in the USA, ideal for individuals with experience in digital transformation initiatives and large-scale manufacturing programs.
Candidates will coordinate extensively with cross-functional teams including Manufacturing, Quality Assurance, IT, Automation, and Validation. Key duties include financial tracking, budget management, and stakeholder communication to provide progress updates and leadership reviews. The role also requires overseeing change control processes and ensuring all technical documentation meets GxP, GMP, GAMP5, and 21 CFR Part 11 standards. This is an onsite position based in the USA, ideal for individuals with experience in digital transformation initiatives and large-scale manufacturing programs.
Key Requirements
Manage full project lifecycle including planning, execution, and delivery phases.
Develop and maintain detailed project plans, schedules, and milestones.
Define project scope, resource requirements, and risk management strategies.
Track timelines, budgets, and overall project performance metrics.
Handle financial tracking, reporting, and funding coordination for assigned projects.
Coordinate effectively with cross-functional teams like QA, IT, Automation, and Validation.
Oversee change control, documentation, and regulatory compliance within a GxP environment.
Ensure strict adherence to GMP, GAMP5, and 21 CFR Part 11 standards.
Bachelor’s degree in Engineering, Life Sciences, IT, or a related field of study.
Minimum of 5+ years of Project Management experience specifically in Pharma or Life Sciences.
Proficiency in project management tools such as MS Project or Primavera.
Strong communication skills for managing stakeholder updates and leadership reviews.