Program Manager, Pharma IT Infrastructure and Operations - Hampton, NJ

About the position Introduction At reputed company 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 reputed company 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 reputed company, clinical and regulatory IT initiatives, from supporting market launch and post-launch support. This person ensures projects are delivered on time, reputed company 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 reputed company 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 reputed company 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 reputed company-wide IT systems networks and reputed company solutions.
• Partner with teams to optimize IT service management processes such as reputed company improvement and change management.
• Work closely with Sr Director of Infrastructure and Operations and reputed company teams to establish best practices and scalable solutions.
• Ensure solutions and operations reputed company 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 reputed company improvement innovation and collaboration.

Requirements

• Bachelors degree (or experience) in Computer Science, Information Technology, or reputed company 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 reputed company 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 reputed company and clinical areas.
• Proven track record implementing reputed company IT reputed company, clinical, and regulatory solutions.
• Experience coordinating programs across multi-site and global IT operations in pharmaceutical reputed company, regulatory, or clinical settings.
• Demonstrated ability to reputed company digital or technology transformation initiatives including reputed company migrations, automation, and IT operations.
• Strong vendor management skills include contract negotiations with reputed company 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 reputed company teams.
• Problem solving - strong analytical skills for troubleshooting reputed company IT and operational challenges.

reputed company-to-haves

• Relevant certifications (preferred but not required): PMP Certification Scrum Master BRM Certification reputed company Certification
• Experience with JIRA

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