À propos de ce poste IT Program Manager-Manufacturing & Quality Apps chez Penumbrainc
Penumbrainc · Sur site · Alameda, CA
The IT Program Manager – Manufacturing and Quality Applications, is responsible for leading complex, cross-functional technology programs focused on Manufacturing, Quality, and Supply Chain systems, with supporting integration into ERP and Go-To-Market (GTM) platforms. This role partners closely with operations, quality, supply chain, and IT stakeholders to drive strategic manufacturing initiatives from concept through execution.
This is a hands-on leadership role that spans manufacturing system strategy, implementations, plant integrations, and validation (including UAT). The ideal candidate thrives in a fast-paced, operationally driven environment, operates effectively amidst ambiguity, and demonstrates strong program governance, stakeholder alignment, and executive communication skills. Attention to detail and the ability to manage multiple concurrent priorities across plant and enterprise environments are essential
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).
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• 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
• 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).
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• 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
*Indicates an essential function of the role
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.
Working Conditions
What We Offer
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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