Consent Decree Remediation & Integration Leader (Pittsburgh, PA, Rosemont, IL or Cambridge, MA) In this position you will be the Consent Decree Remediation & Integration Leader that is responsible for the remediation of the Sleep and Respiratory Care (S&RC) products to meet all quality and regulatory requirements as part of our Consent Decree Office (CDO). Your role:
The Consent Decree Remediation and Integration Leader drives simplification, standardization, and compliance in the multiple programs and processes. The role is a member of the S&RC CDO LT and influences other functions within and outside the business.
S/he provides vision and manages complex problems and addresses difficult issues. The leader understands broader implications and has technical depth of electromechanical and consumables design, design history file requirements, manufacturing operations, site quality leadership and audit observation management.
Leverages deep knowledge of FDA regulations and experience leading through consent decrees with other companies to set strategy for agency responses, including advising leadership on strategic approaches, prioritization, communications, capability planning, forecasting, governance, change control and interdependencies.
Builds partnerships with stakeholders (internal/external), leverages them to achieve organizational goals, and able to influence their opinions and negotiate effective solutions,
Leads CD activities and resources across CD to define scope, manage budget, complete predictable planning and achieve product compliance.
Sets up PMO governance, processes, and procedures including tiered daily management to communicate status, escalations, etc with executives at various levels within and outside of S&RC.
Role will be a functional leader and coaches direct reports within the CDO to ensure appropriate capability and the best staffing.
You're the right fit if you have:
Expertise leading a multi-billion dollar business through a consent decree in the US and experience working directly with FDA.
Program management expertise in a matrixed environment with proven business experience in his/her domain (innovation, product development, operations etc.) in various roles.
Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements
Counselor of a broad range of stakeholders, able to have a peer-to-peer relationship with executive business/market leaders and content experts.
Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma).
Executive communication
People management experience
This role is a seasoned advisor, typically requires a master’s degree with> 15 years of related experience in program and portfolio management. PMP Certification preferred
Will consider candidates in Cambridge MA, Pittsburgh PA, Minneapolis MS or Rosemont IL 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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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 $250,000 to $280,0000, 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. 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. 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. It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
