Job Description
About the position Introduction At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstreams industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. Job Summary Contract / Program Manager, Pharma IT Infrastructure and Operations is a pivotal role responsible for executing programs/projects across the entire lifecycle of commercial, clinical and regulatory IT initiatives, from supporting market launch and post-launch support. This person ensures projects are delivered on time, within budget, and meet high-quality standards while aligning with strategic business objectives. You will be responsible for overseeing a portfolio of projects that design, implement, and maintain an organization's IT infrastructure and systems, including software, operations, and data management. Responsibilities • Manage cross-functional IT projects, spearheading process streamlining, training, audits, regulatory readiness, and KPI/metrics tracking to achieve on-time delivery and business objectives. • Analyze and convey risk and compliance adherence principles and practices to institute their adoption and acceptance. • Served as program manager and implemented corrective action plans ensuring responsible parties were assigned, documented, and committed to actions within realistic targets; conducted deep-dive SWOT analysis in categories/ groups of deviations and CAPAs from different sources to coordinate major action plans with IT senior management • Support the design implementation and management of enterprise-wide IT systems networks and cloud solutions. • Partner with teams to optimize IT service management processes such as continuous improvement and change management. • Work closely with Sr Director of Infrastructure and Operations and security teams to establish best practices and scalable solutions. • Ensure solutions and operations comply with GxP, FDA 21 CFR part 11, HIPAA, and ISO 13485 requirements. • Work closely with QA regulatory and compliance teams to align its practices with industry regulations. • Support vendor qualifications and audits for IT systems used in GxP environments. • Draft and maintain comprehensive documentation and SOPs for IT processes to meet adoption and audit requirements. • Contribute to the culture of continuous improvement innovation and collaboration. Requirements • Bachelors degree (or experience) in Computer Science, Information Technology, or related field. • 7 plus years of IT experience with at least 3 to 5 years in leadership roles overseeing IT projects and programs. • 5 plus years of program management experience with at least 3-5 years of commercial pharma experience. • Strong experience in regulated environments (Pharmaceutical, Biotech, Clinical or Medical Device industries). • Strong understanding of GXP, FDA 21 CFR part 11, HIPAA, GDPR, and ISO 27001 compliance. • Experience in data warehousing, reporting and analytical project implementation in commercial and clinical areas. • Proven track record implementing enterprise IT commercial, clinical, and regulatory solutions. • Experience coordinating programs across multi-site and global IT operations in pharmaceutical commercial, regulatory, or clinical settings. • Demonstrated ability to lead digital or technology transformation initiatives including cloud migrations, automation, and IT operations. • Strong vendor management skills include contract negotiations with cloud providers, IT service partners, and managed services organizations. • Strategic thinking - ability to align IT infrastructure and operations with business and regulatory needs. • Collaboration and communication - ability to work across R&D, clinical, manufacturing, regulatory, and commercial teams. • Problem solving - strong analytical skills for troubleshooting complex IT and operational challenges. Nice-to-haves • Relevant certifications (preferred but not required): PMP Certification Scrum Master BRM Certification Smartsheet Certification • Experience with JIRA Apply tot his job