Sr. Program Manager-Risk Management/Consent Decree
Location
Plymouth, MA | United States
Job description
Job TitleSr. Program Manager-Risk Management/Consent Decree
Job Description
The Sr. Program Manager-Risk Management/Consent Decree will play a critical role in ensuring the Quality, Safety, and compliance of Philips’ Sleep & Respiratory (S&RC) products through leading the transformation of the S&RC Quality Management System, with a focus on Risk Management, Product and Manufacturing processes to meet all quality and regulatory requirements as part of our Consent Decree Office (CDO).
Your role:
- As a critical member of the S&RC Consent Decree Organization (CDO), the Sr. Program Manager is a high visibility role drives simplification, standardization, and compliance in the global sites through a variety of programs and processes, with a focus on electromechanical design, history file/design transfer requirements, and CAPA management.
- Will provide vision, strategy, understand broader implications and possesses technical depth in the focus areas, as well as integrating self-audit findings and best practices from other businesses across Philips into the future S&RC product portfolio.
- Accountable for the program plan/schedule and resolves interdependencies with other processes in the quality system. Represents Quality Systems and Product Risk Management in PMO governance mechanisms including tiered daily management. Acts as the single point of accountability to communicate status, escalations, etc. with executives at various levels within S&RC.
- Reporting to the Program Director- Consent Decree, you will partner with subject matter experts within and outside CDO to ensure appropriate capability and change plans are in-place for the S&RC business. You will also collaborate with consultants to ensure the new system meets today’s compliance standards and has flexibility to accommodate future agency trends and guidance.
- This Hybrid role , may require travel up to 25%.
You're the right fit if:
- You’ve acquired a minimum of 7 years’ experience in Program/Project management in FDA regulated Medical Device (REQUIRED, matrixed environments, with proven business experience in quality systems (QMS), audit, Change Control, Complaints, Training, Product Risk Management processes, electromechanical design, design history file requirements, and CAPA management.
- You have proven expertise in all aspects of program planning and execution, demonstrating an outstanding record of project management success, both in results achieved and in use of professional methodology. PMP Certification preferred.
- You have detailed knowledge of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.
- You’re able to influence and effectively communicate with a broad range of stakeholders at all levels, including peer-to-peer relationships with executive business/market leaders and content experts.
- You’re a self-starter, skilled in driving continuous improvement in a matrixed environment, leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma).
- You have a minimum of a Bachelor’s Degree (required), Master’s degree (preferred).
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details:
The pay range for this position is $107,000 to $199,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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