Sr. Program Manager- Product & Process Development & Remediation, Consent Decree

Job Title

Sr. Program Manager- Product & Process Development & Remediation, Consent Decree

Job Description

Sr. Program Manager - Product & Process Development and Remediation, Compliance Programs

This role leads portfolio & program management initiatives for product remediation efforts tied to broad compliance initiatives such as European Medical Device Regulation (EU-MDR) and U.S. Consent Decree remediation. This role drives simplification, standardization, and product compliance with a focus on design & development, CAPA’s, and the associated process & production controls in our global manufacturing sites.

Your role:

• Provide vision, strategy, and manage complex problems and address difficult issues. You, as the leader, understand broader implications and have technical depth of electromechanical design, design history file requirements, end-of-life process, Quality Systems (e.g., CFR Part 820) and CAPA management.
• Serve as program manager and lead cross-functional core teams, working to establish, maintain, and track scope, schedule, milestones, program risks and other key program management deliverables. 
• Function as the portfolio manager and partner with the business and R&D leadership to ensure the portfolio meets today’s needs and is aligned with innovation and product roadmaps to deliver on our commitments to our patients.
• Manage audit outcomes and integrate self-audit findings into the processes that define our products. 
• Be accountable for the program plan & schedule and resolve interdependence with other workstreams.
• Represent Product & Process Development and Remediation in Project Management Office (PMO) governance mechanisms. Act as the single point of accountability to communicate status, escalations, etc. with executives at various levels within Sleep & Respiratory Care (S&RC).

You're the right fit if:

• You’ve acquired 7+ years of related experience in program and portfolio management and have program management expertise in a matrixed environment with proven business experience in your domain (innovation, product development, quality assurance, operations etc.) in various roles.
• You have a bachelor’s required. PMP Certification preferred. A master’s degree in science, engineering, or a related field preferred,
• You have experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Experience working to address larger compliance issues such as consent decrees, warning letters, 483s, recalls, and EU MDR remediation is strongly preferred.
• Your skills include a good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device development process requirements. You have a strong background in remediation efforts, and CAPA’s.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 
• You’re a counselor of a broad range of stakeholders, able to have a peer-to-peer relationship with executive business/market leaders and content experts. You have excellent executive communication skills.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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