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Pharma Director of IT Supply Chain & Manufacturing Systems

SlipStream I.T. Inc

At Slipstream, 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.

Slipstream's 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

The Director of IT Supply Chain & Manufacturing Systems is a technology leadership role responsible for the design, implementation, and optimization of enterprise information systems that power pharmaceutical supply chain and manufacturing operations - with a primary focus on enabling the successful commercial launch of new products. This individual serves as the critical bridge between IT and business functions including Supply Chain, Manufacturing, Regulatory Affairs, and Quality Assurance.

This role requires a rare combination of deep pharmaceutical domain knowledge and enterprise technology expertise. The ideal candidate has led large-scale IT program implementations in a GxP-regulated environment, understand the data and systems dependencies inherent to product launches, and can translate complex technical requirements into actionable delivery roadmaps aligned with business milestones.

Responsibilities
New Product Launch Leadership
  • Lead integrated supply chain IT readiness activities for pipeline products transitioning from clinical to commercial manufacturing.
  • Develop and own systems to support launch supply plans, including demand forecasting, inventory buildup strategies, and risk mitigation scenarios.
  • Partner with Regulatory Affairs to ensure IT systems align manufacturing scale-up timelines with submission and approval milestones.
  • Drive stage-gate IT launch readiness reviews in coordination with Program Management, Commercial, and QA teams.
  • Develop and manage reporting systems to support the creating and reporting of product launch KPIs.
Enterprise Systems & ERP Program Management
  • Own the IT roadmap for supply chain and manufacturing systems, including but not limited to ERP (SAP S/4HANA, Oracle), MES (Manufacturing Execution Systems), LIMS, and WMS platforms.
  • Support ERP implementations and upgrades in support of new product launch readiness, from identifying requirements through hypercare stabilization.
  • Define and govern IT system's integration architecture connecting planning, manufacturing, quality, serialization, and distribution platforms.
  • Ensure that all IT system configurations, master data structures, and business rules are aligned with new product requirements ahead of commercial launch.
  • Serve as the IT lead for data migration and master data governance for new product introductions, including SKU setup, bill of materials, and batch management.
Supply Chain Planning Systems & Digital Tools
  • Lead the implementation and optimization of supply chain planning platforms (e.g., Kinaxis RapidResponse, Blue Yonder, o9 Solutions) to support demand sensing, S&OP, and inventory management for new products.
  • Enable real-time supply chain visibility capabilities, including control tower dashboards, supplier portals, and launch readiness scorecards.
  • Support digital demand forecasting tools and collaborate with Commercial Analytics teams to incorporate market intelligence into pre-launch inventory models.
  • Drive adoption of advanced analytics and AI/ML capabilities to improve forecast accuracy and supply risk prediction across the product portfolio.
  • Establish data pipelines and reporting infrastructure to support launch KPI monitoring and executive-level status communication as defined by IT leadership.
Manufacturing IT & MES Implementation
  • Lead IT workstreams for manufacturing technology transfers, including system cutover planning, MES configuration, and production data migration.
  • Partner with Manufacturing and Engineering teams to implement and validate Manufacturing Execution Systems (MES) at commercial production sites and CMO locations (if applicable).
  • Manage IT components of process validation and equipment qualification (IQ/OQ/PQ) to ensure systems are launch-ready and GMP-compliant.
  • Support implementation of electronic batch records (EBR), shop floor data collection, and OEE monitoring systems in support of commercial manufacturing readiness.
  • Partner with IT Leadership to define IT architecture for serialization and track-and-trace compliance (DSCSA, EU FMD) across manufacturing and distribution nodes for new product launches.
GxP Compliance, Validation & Cybersecurity
  • Ensure all supply chain and manufacturing IT systems meet GxP, 21 CFR Part 11, EU Annex 11, and applicable data integrity regulatory requirements.
  • Own and govern the Computer System Validation (CSV) / Computer Software Assurance (CSA) lifecycle for regulated systems supporting product launch.
  • Maintain audit-ready validation documentation and support regulatory inspections (PAIs, FDA, EMA) with IT evidence packages.
  • Partner with Information Security to implement cybersecurity controls for OT/IT environments at manufacturing sites, including network segmentation and access management.
  • Ensure data integrity, backup, and disaster recovery capabilities are in place for all systems critical to launch operations.
Cross-Functional IT Partnership & Governance
  • Serve as the primary IT representative on New Product Launch Teams, ensuring technology workstreams are fully integrated into launch plans and gate reviews.
  • Build and manage relationships with system integrators, technology vendors, and managed service providers supporting supply chain and manufacturing IT.
  • Develop and manage IT project budgets, resource plans, and vendor contracts for supply chain and manufacturing technology programs.
  • Lead and develop a high-performing team of IT project managers, business analysts, and system specialists aligned to supply chain and manufacturing domains.
  • Present IT program status, risk, and investment cases to C-suite, Supply Chain leadership, and Board-level technology committees.

Qualifications
Education
  • Bachelor's degree required in Information Technology, Computer Science, Supply Chain Management, Engineering, or a related discipline.
  • Master's degree (MBA, MS in Information Systems, or MS in Supply Chain) strongly preferred.
  • PMP, SAP Certified Application Associate, APICS CSCP/CPIM, or GAMP 5 practitioner certification is a strong plus.
Experience
  • Minimum 12+ years of progressive IT experience, with at least 7 years focused on supply chain and/or manufacturing systems in the pharmaceutical or life sciences industry.
  • Minimum 5 years in a director-level IT leadership role managing cross-functional programs and direct reports.
  • Demonstrated experience leading IT workstreams for at least 2-3 commercial pharmaceutical product launches, including ERP readiness, system validation, and launch cutover.
  • Proven track record delivering large-scale ERP, MES, or supply chain planning system implementations in a GxP-regulated environment.
  • Experience managing IT at or in close partnership with Contract Manufacturing Organizations (CMOs) and CDMOs.
  • Exposure to biologics, cell & gene therapy, or specialty pharmaceutical manufacturing IT environments is a plus.
Technical Skills
  • Deep proficiency with pharmaceutical ERP platforms: SAP S/4HANA (MM, PP, WM/EWM, SD, QM modules), Oracle, or equivalent.
  • Hands-on experience with supply chain planning tools: Kinaxis RapidResponse, Blue Yonder, o9 Solutions, or similar APS platforms.
  • Working knowledge of MES platforms (Rockwell PharmaSuite, Siemens Opcenter, Werum PAS-X) and LIMS systems (LabVantage, LabWare).
  • Familiarity with serialization platforms (TraceLink, rfxcel), warehouse management systems, and cold chain monitoring technologies.
  • Understanding of computer system validation (CSV/CSA) methodology under GAMP 5 and 21 CFR Part 11 / EU Annex 11 requirements.
  • Experience with data integration technologies (API management, ETL tools, middleware) and cloud platforms (Azure, AWS) in regulated environments.
Leadership Competencies
  • Strategic systems thinking - ability to architect IT solutions that anticipate the full lifecycle needs of a product from launch through loss of exclusivity.
  • Regulated environment savvy - instinctively balances speed-to-market urgency with GxP compliance and data integrity rigor.
  • Influence without authority - skilled at aligning IT priorities with business stakeholders who may not understand technology constraints.
  • Executive communication - able to translate complex IT program status, risk, and investment decisions for non-technical business leaders.
  • Delivery leadership - proven ability to manage multiple concurrent programs on time, on budget, and to specification in fast-moving launch environments.

Slipstream is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.
Vacancy posted 3 days ago
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