Koninklijke Philips N.V - New Haven, CT
posted about 1 month ago
The Sr. Program Manager for Product & Process Development and Remediation plays a pivotal role in driving simplification, standardization, and compliance of products within the framework of the Consent Decree (CD) response. This position is integral to the Product Remediation effort, focusing on design and development, Corrective and Preventive Actions (CAPA), and the associated process and production controls across global manufacturing sites. As a leader in this domain, you will provide vision and strategy while managing complex problems and addressing challenging issues that arise in the course of product development and remediation. In this role, you will act as the project manager, collaborating closely with business and R&D leadership to ensure that the product portfolio aligns with current needs and innovation roadmaps. You will be responsible for managing audit outcomes and integrating self-audit findings into the processes that define our products. Accountability for the program plan and schedule is crucial, as is the ability to resolve interdependencies with other workstreams related to the Consent Decree. You will represent Product & Process Development and Remediation in Project Management Office (PMO) governance mechanisms, serving as the single point of accountability for communicating status updates and escalations to executives at various levels within the Sleep & Respiratory Care (S&RC) division. The ideal candidate will have a strong background in program and portfolio management, with at least 8 years of relevant experience in a matrixed environment. You should possess expertise in process improvement methodologies such as Lean, Hoshin, or Six Sigma, and have a solid understanding of Quality System Regulations including ISO 9001, ISO 13485, and 21 CFR Part 803, 806, and 820. A master's degree in science, engineering, or a related field is required, and PMP certification is preferred. Excellent executive communication skills and the ability to build peer-to-peer relationships with stakeholders are essential for success in this role.