Philips North America - Pittsburgh, PA
posted about 1 month ago
The Sr. Program Manager for Product & Process Development and Remediation plays a pivotal role in driving simplification, standardization, and product compliance 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, the individual will provide vision and strategy while managing complex problems and addressing challenging issues that arise in the course of product development and compliance. In this role, the Sr. Program Manager will act as a project manager, collaborating closely with business and R&D leadership to ensure that the product portfolio aligns with current needs and innovation roadmaps. This includes managing audit outcomes and integrating self-audit findings into the processes that define the products. The individual will be accountable for the program plan and schedule, resolving interdependencies with other CD workstreams, and representing Product & Process Development and Remediation in Project Management Office (PMO) governance mechanisms. This position requires effective communication with executives at various levels within the Sleep & Respiratory Care (S&RC) division, serving as the single point of accountability for status updates and escalations. The ideal candidate will possess a deep understanding of electromechanical design, design history file requirements, and Quality Systems, including compliance with regulations such as CFR Part 820. With over 8 years of experience in program and portfolio management, the candidate should have a proven track record in a matrixed environment, demonstrating expertise in innovation, product development, and quality assurance. Familiarity with process improvement methodologies such as Lean, Hoshin, or Six Sigma is essential, along with a solid grasp of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820). A master's degree in science, engineering, or a related field is required, with PMP certification preferred. The role demands excellent executive communication skills and the ability to foster peer-to-peer relationships with stakeholders across the organization.