Sr. Program Manager- Product & Process Development & Remediation, Consent Decree
Sr. Program Manager- Product & Process Development & Remediation, Consent Decree
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$ 139440 - 223104
1 Vacancy
Job Description
Job Title
Sr. Program Manager- Product & Process Development & Remediation Consent DecreeJob 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 CAPAs and the associated process & production controls in our global manufacturing sites.
Your role:
- Providevision strategyand 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 todays 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).
Youre the right fit if:
- Youve 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 bachelors required. PMP Certification preferred. A masters 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 ISOCFR Part 803 806 & 820) and knowledge of medical device development process requirements. You have a strong background in remediation efforts and CAPAs.
- You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
- Youre 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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.
- Learn more about our culture.
Philips Transparency Details
The pay range for this role in Pittsburgh PA is $124500 to $199200
The pay range for this in Plymouth MN is $130725 to $209160.
The pay range for this role in Cambridge MA is $139440 to $223104.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills experience business needs geographical location and internal equity.
In addition other compensation such as an annual incentive bonus sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program which includes a generous PTO 401k (up to 7% match) HSA (with company contribution) stock purchase plan education reimbursement and much more. Details about our benefits can be found here.
At Philips it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
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.
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Required Experience:
Manager
Employment Type
Full-Time
