Sr. Director, IT-R&D, Manufacturing, Quality, and Regulatory
h3Position Summary /h3pembecta 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. /ppPosition Summary The Sr. Director, IT-RD, 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 RD as the function's data, document, and lab-system needs mature, and for Regulatory as submission and compliance technology needs evolve. RD and Regulatory Technology scope is absorbed within this role's existing team, not through additional headcount. /ph3Key Responsibilities /h3ulliPlatform technical ownership /liliOwn 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. /liliOwn SAP Manufacturing functional areas (Production Planning, Quality Management) supporting plant operations. /liliOwn GxP validation and compliance systems, including IQ/OQ/PQ documentation, with US sign-off retained. /liliOwn quality systems supporting manufacturing and compliance across all sites. /liliOwn the RD technology roadmap (research systems, RD data and document management, lab systems) as this scope matures. /liliOwn the Regulatory technology roadmap (regulatory submission systems and compliance tooling) as this scope matures. /liliEnsure system integration and data quality across plant, quality, and regulatory platforms, including data residency requirements at international sites (e.g., China). /li /ulh3Regional Plant Leadership /h3ulliLead 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. /liliOwn 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. /liliManage the T3 escalation path from plant engineers through the MES vendor-managed service. /liliPartner with regional business and plant leaders to adopt global technology standards while accommodating local regulatory needs. /li /ulh3Strategic partnership governance /h3ulliServe as the primary IT owner and executive partner to Manufacturing, Quality, RD, and Regulatory leadership. As a member of the IT Leadership Team reporting to the CIO, contribute the RD/Manufacturing/Quality/Regulatory perspective to enterprise-wide technology strategy and ensure alignment with peer pillars. /liliOwn project intake, prioritization, and portfolio governance for functions in scope. /liliPartner with Enterprise Architecture Design Governance to ensure solutions comply with security, data, and architectural standards. /liliManage vendor relationships and contracts for MES and related platforms, including licensing, renewals, and SLA performance. /li /ulh3Risk, security compliance /h3ulliEnsure 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. /liliPartner 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. /liliMaintain working knowledge of GxP validation requirements and data residency obligations for international plant sites (e.g., China). /liliPartner with Commercial GA IT where Sales and Marketing systems intersect with promotional material review and regulatory compliance.
/li /ulh3People leadership /h3ulliLead the regional Sr Managers and, through them, the Plant IT Engineers and GxP Validation Analyst that make up this pillar. /liliAbsorb RD and Regulatory Technology scope within the existing team as these responsibilities take shape, prioritizing and sequencing the work across current roles. /liliBuild a succession and development plan for the team. /liliFoster a culture of accountability, quality-first thinking, and continuous improvement across a globally distributed plant IT team. /li /ulh3Required Qualifications /h3ulli10+ years of progressive IT leadership experience, including direct experience with Manufacturing Execution Systems (MES), GxP validation, and plant-floor IT in a regulated manufacturing environment (medical device, pharma, or similar preferred). /liliExperience leading globally distributed plant IT teams across multiple regions (Americas, EMEA, APAC). /liliExperience managing MES vendor-managed services, including SLA management and escalation processes. /liliWorking knowledge of FDA Quality System Regulation, GxP validation (IQ/OQ/PQ), and data residency requirements for international operations. /liliExperience partnering with OT/cybersecurity teams on plant-floor security. /liliExposure to RD technology (lab systems, RD data management) and regulatory technology (submission systems) is a plus, given this role's expanding scope. /liliBased in the EU, with regular travel to global plant sites (Americas, APAC). /liliBachelor's degree in Information Technology, Engineering, or a related field; MBA or advanced degree a plus. /li /ulpembecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. /ppAt embecta, a career is more than a job, it is an opportunity to make a meaningful difference in the lives of about 30 million people around the world who depend on our products to manage a chronic condition every single day. As we expand our capabilities, reach, and impact, there’s never been a more exciting time to join us. /p #J-18808-Ljbffr
China) — each owning their regional Plant IT Engineering team. /liliOwn 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. /liliManage the T3 escalation path from plant engineers through the MES vendor-managed service. /liliPartner with regional business and plant leaders to adopt global technology standards while accommodating local regulatory needs. /li /ulh3Strategic partnership governance /h3ulliServe as the primary IT owner and executive partner to Manufacturing, Quality, RD, and Regulatory leadership. As a member of the IT Leadership Team reporting to the CIO, contribute the RD/Manufacturing/Quality/Regulatory perspective to enterprise-wide technology strategy and ensure alignment with peer pillars. /liliOwn project intake, prioritization, and portfolio governance for functions in scope. /liliPartner with Enterprise Architecture Design Governance to ensure solutions comply with security, data, and architectural standards. /liliManage vendor relationships and contracts for MES and related platforms, including licensing, renewals, and SLA performance. /li /ulh3Risk, security compliance /h3ulliEnsure 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. /liliPartner 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. /liliMaintain working knowledge of GxP validation requirements and data residency obligations for international plant sites (e.g., China). /liliPartner with Commercial GA IT where Sales and Marketing systems intersect with promotional material review and regulatory compliance.
/li /ulh3People leadership /h3ulliLead the regional Sr Managers and, through them, the Plant IT Engineers and GxP Validation Analyst that make up this pillar. /liliAbsorb RD and Regulatory Technology scope within the existing team as these responsibilities take shape, prioritizing and sequencing the work across current roles. /liliBuild a succession and development plan for the team. /liliFoster a culture of accountability, quality-first thinking, and continuous improvement across a globally distributed plant IT team. /li /ulh3Required Qualifications /h3ulli10+ years of progressive IT leadership experience, including direct experience with Manufacturing Execution Systems (MES), GxP validation, and plant-floor IT in a regulated manufacturing environment (medical device, pharma, or similar preferred). /liliExperience leading globally distributed plant IT teams across multiple regions (Americas, EMEA, APAC). /liliExperience managing MES vendor-managed services, including SLA management and escalation processes. /liliWorking knowledge of FDA Quality System Regulation, GxP validation (IQ/OQ/PQ), and data residency requirements for international operations. /liliExperience partnering with OT/cybersecurity teams on plant-floor security. /liliExposure to RD technology (lab systems, RD data management) and regulatory technology (submission systems) is a plus, given this role's expanding scope. /liliBased in the EU, with regular travel to global plant sites (Americas, APAC). /liliBachelor's degree in Information Technology, Engineering, or a related field; MBA or advanced degree a plus. /li /ulpembecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. /ppAt embecta, a career is more than a job, it is an opportunity to make a meaningful difference in the lives of about 30 million people around the world who depend on our products to manage a chronic condition every single day. As we expand our capabilities, reach, and impact, there’s never been a more exciting time to join us. /p #J-18808-Ljbffr