IT Program Manager-Manufacturing & Quality Apps
Penumbra, Inc. · Alameda, CA · Yesterday
On-siteProject Management$158k–$223k/yrFull-time
What You'll Work On
- Own and manage the full lifecycle of complex, high-impact programs focused on Manufacturing, Quality, and Supply Chain applications, with integration into ERP and GTM systems.
- Partner with Manufacturing, Quality, and Operations leaders to define program objectives, scope, and success criteria aligned to plant and enterprise goals.
- Develop and maintain the Manufacturing IT strategic roadmap, ensuring alignment with production scalability, quality compliance, and operational efficiency.
- Drive global manufacturing process standardization, digitization, and system optimization across plants and regions.
- Lead program portfolio management for manufacturing initiatives, including prioritization, capacity planning, and dependency management across sites.
- Lead end-to-end delivery of manufacturing system implementations and enhancements (e.g., MES, QMS, shop floor systems, traceability, and production planning tools).
- Oversee integration of manufacturing systems with ERP, warehouse management, and downstream GTM platforms.
- Define and execute program governance, including communication plans, stakeholder engagement, and executive reporting with a strong focus on operational impact.
- Monitor program performance using KPIs tied to production efficiency, quality, compliance, and throughput.
- Identify, assess, and mitigate risks, particularly those impacting production continuity, regulatory compliance, and plant operations.
- Collaborate with cross-functional teams (Manufacturing, Quality, Supply Chain, IT) to define scope, timelines, and resource requirements.
- Ensure solutions are delivered on time, within budget, and meet plant operational and quality expectations.
- Lead validation and testing strategies, including integration testing, UAT, and manufacturing system validation in regulated environments.
- Drive change management across plant users, including training, communication, and adoption of new manufacturing processes and systems.
- Facilitate strong collaboration between IT and plant operations teams to ensure alignment and minimal disruption to production.
- Maintain comprehensive program documentation, including validation artifacts, risks, and compliance records.
- Conduct post-implementation reviews focused on operational improvements, production metrics, and continuous improvement.
- Ensure adherence to PMO standards, quality frameworks, and regulatory requirements (e.g., QMS, GxP where applicable).
- Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
- Perform other work-related duties as assigned.
What You'll Bring
- Minimum education and experience: Bachelor's degree with 10+ years of experience in program and project management, or equivalent combination of education and experience.
- Additional qualifications: PMP, Agile, or Scrum certifications preferred.
- Solid experience in program and project management in manufacturing, medical devices, or life science environments.
- Proven experience leading large-scale programs in Manufacturing and Quality systems (e.g., MES, QMS, production planning, shop floor automation), with ERP integration.
- Strong understanding of Plan-to-Produce, Quality Management, Inventory Management, and Supply Chain processes.
- Experience working in regulated manufacturing environments, including system validation and compliance (QMS, FDA, ISO).
- Hands-on experience with manufacturing system implementations, plant rollouts, and multi-site deployments.
- Medical device, pharmaceutical, biotech, or other regulated industry experience desired.
- Experience managing testing strategies, including validation, integration testing, UAT, and cutover planning with hypercare support.