Sr. Director, IT-R&D, Manufacturing, Quality, and Regulatory
Position Summary
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.
Position Summary The Sr. Director, IT-R&D;, Manufacturing, Quality, and Regulatory owns IT strategy and delivery for embecta's manufacturing, quality, and regulatory technology globally — Manufacturing Execution Systems (MES), SAP Manufacturing, GxP validation and compliance systems, quality systems, and the regulatory technology supporting a global medical device manufacturer — across 6 plant sites spanning Americas, EMEA, and APAC. This role owns the largest share of Run Reliably for plant-facing systems: MES uptime, GxP compliance, and quality-system integrity across every manufacturing site embecta operates. It is also the natural technology partner for R&D; as the function's data, document, and lab-system needs mature, and for Regulatory as submission and compliance technology needs evolve. R&D; and Regulatory Technology scope is absorbed within this role's existing team, not through additional headcount.
Key Responsibilities
- Platform & technical ownership
- Own Manufacturing Execution Systems (MES) strategy and delivery across all 6 global plant sites, including the vendor-managed MES service (Rockwell/Siemens) and its 4-hour critical SLA.
- Own SAP Manufacturing functional areas (Production Planning, Quality Management) supporting plant operations.
- Own GxP validation and compliance systems, including IQ/OQ/PQ documentation, with US sign-off retained.
- Own quality systems supporting manufacturing and compliance across all sites.
- Own the R&D; technology roadmap (research systems, R&D; data and document management, lab systems) as this scope matures.
- Own the Regulatory technology roadmap (regulatory submission systems and compliance tooling) as this scope matures.
- Ensure system integration and data quality across plant, quality, and regulatory platforms, including data residency requirements at international sites (e.g., China).
Regional & Plant Leadership
- Lead the regional Sr Managers — Americas Plants IT (Holdrege, NE), EMEA Plants IT (Dun Laoghaire, Ireland), and APAC Plants IT (Suzhou, China) — each owning their regional Plant IT Engineering team.
- Own Plant IT Engineering across all 6 sites (Holdrege NE, Dun Laoghaire, two UK sites, Suzhou China, Malaysia), covering MES, EHS, GxP, and OM-integration support at each location.
- Manage the T3 escalation path from plant engineers through the MES vendor-managed service.
- Partner with regional business and plant leaders to adopt global technology standards while accommodating local regulatory needs.
Strategic partnership & governance
- Serve as the primary IT owner and executive partner to Manufacturing, Quality, R&D;, and Regulatory leadership. As a member of the IT Leadership Team reporting to the CIO,
contribute the R&D;/Manufacturing/Quality/Regulatory perspective to enterprise-wide technology strategy and ensure alignment with peer pillars.
- Own project intake, prioritization, and portfolio governance for functions in scope.
- Partner with Enterprise Architecture & Design Governance to ensure solutions comply with security, data, and architectural standards.
- Manage vendor relationships and contracts for MES and related platforms, including licensing, renewals, and SLA performance.
Risk, security & compliance
- Ensure MES, GxP, quality, and regulatory systems meet FDA Quality System Regulation (21 CFR Part 820) requirements and other applicable regulatory standards for medical device manufacturing.
- Partner with the CISO/Infrastructure organization on OT security — OT Security Engineers sit within the CISO & Infrastructure pillar with a plant-level dotted line to this role.
- Maintain working knowledge of GxP validation requirements and data residency obligations for international plant sites (e.g., China).
- Partner with Commercial & G&A; IT where Sales and Marketing systems intersect with promotional material review and regulatory compliance.
People leadership
- Lead the regional Sr Managers and, through them, the Plant IT Engineers and GxP Validation Analyst that make up this pillar.
- Absorb R&D; and Regulatory Technology scope within the existing team as these responsibilities take shape, prioritizing and sequencing the work across current roles.
- Build a succession and development plan for the team.
- Foster a culture of accountability, quality-first thinking, and continuous improvement across a globally distributed plant IT team.
Required Qualifications
- 10+ y
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.
Position Summary The Sr. Director, IT-R&D;, Manufacturing, Quality, and Regulatory owns IT strategy and delivery for embecta's manufacturing, quality, and regulatory technology globally — Manufacturing Execution Systems (MES), SAP Manufacturing, GxP validation and compliance systems, quality systems, and the regulatory technology supporting a global medical device manufacturer — across 6 plant sites spanning Americas, EMEA, and APAC. This role owns the largest share of Run Reliably for plant-facing systems: MES uptime, GxP compliance, and quality-system integrity across every manufacturing site embecta operates. It is also the natural technology partner for R&D; as the function's data, document, and lab-system needs mature, and for Regulatory as submission and compliance technology needs evolve. R&D; and Regulatory Technology scope is absorbed within this role's existing team, not through additional headcount.
Key Responsibilities
- Platform & technical ownership
- Own Manufacturing Execution Systems (MES) strategy and delivery across all 6 global plant sites, including the vendor-managed MES service (Rockwell/Siemens) and its 4-hour critical SLA.
- Own SAP Manufacturing functional areas (Production Planning, Quality Management) supporting plant operations.
- Own GxP validation and compliance systems, including IQ/OQ/PQ documentation, with US sign-off retained.
- Own quality systems supporting manufacturing and compliance across all sites.
- Own the R&D; technology roadmap (research systems, R&D; data and document management, lab systems) as this scope matures.
- Own the Regulatory technology roadmap (regulatory submission systems and compliance tooling) as this scope matures.
- Ensure system integration and data quality across plant, quality, and regulatory platforms, including data residency requirements at international sites (e.g., China).
Regional & Plant Leadership
- Lead the regional Sr Managers — Americas Plants IT (Holdrege, NE), EMEA Plants IT (Dun Laoghaire, Ireland), and APAC Plants IT (Suzhou, China) — each owning their regional Plant IT Engineering team.
- Own Plant IT Engineering across all 6 sites (Holdrege NE, Dun Laoghaire, two UK sites, Suzhou China, Malaysia), covering MES, EHS, GxP, and OM-integration support at each location.
- Manage the T3 escalation path from plant engineers through the MES vendor-managed service.
- Partner with regional business and plant leaders to adopt global technology standards while accommodating local regulatory needs.
Strategic partnership & governance
- Serve as the primary IT owner and executive partner to Manufacturing, Quality, R&D;, and Regulatory leadership. As a member of the IT Leadership Team reporting to the CIO,
contribute the R&D;/Manufacturing/Quality/Regulatory perspective to enterprise-wide technology strategy and ensure alignment with peer pillars.
- Own project intake, prioritization, and portfolio governance for functions in scope.
- Partner with Enterprise Architecture & Design Governance to ensure solutions comply with security, data, and architectural standards.
- Manage vendor relationships and contracts for MES and related platforms, including licensing, renewals, and SLA performance.
Risk, security & compliance
- Ensure MES, GxP, quality, and regulatory systems meet FDA Quality System Regulation (21 CFR Part 820) requirements and other applicable regulatory standards for medical device manufacturing.
- Partner with the CISO/Infrastructure organization on OT security — OT Security Engineers sit within the CISO & Infrastructure pillar with a plant-level dotted line to this role.
- Maintain working knowledge of GxP validation requirements and data residency obligations for international plant sites (e.g., China).
- Partner with Commercial & G&A; IT where Sales and Marketing systems intersect with promotional material review and regulatory compliance.
People leadership
- Lead the regional Sr Managers and, through them, the Plant IT Engineers and GxP Validation Analyst that make up this pillar.
- Absorb R&D; and Regulatory Technology scope within the existing team as these responsibilities take shape, prioritizing and sequencing the work across current roles.
- Build a succession and development plan for the team.
- Foster a culture of accountability, quality-first thinking, and continuous improvement across a globally distributed plant IT team.
Required Qualifications
- 10+ y