25 days old

Quality & Regulatory Competency & Education Director

Philips Electronics North America Corp
Boston
  • Job Code
    112225348

In this role, you have the opportunity to

Lead all aspects of effective, efficient, consistent and integrated compliance learning approach from a global perspective. Develops and leads the global compliance learning approach across all Philips markets, businesses and functions. Drives the design of compliance learning in his/her area
Ensures high quality business needs analyses intake with senior leaders, markets, businesses or functions and ensures overall alignment with the business strategy and university portfolio management

You are responsible for

· Build and improve a Global integrated Q&R training program (curriculum, delivery methods, effectiveness checking, record creation/management)

· Partners with Philips University team to eliminate redundant compliance training and ensure training curriculums in the Compliance domain and Philips University are complimentary

· Develop a Center of Excellence in the use of educational materials, methods, techniques and record capturing

· Ensures effective and high quality Quality, Clinical and Regulatory compliance learning

· Development of formal learning program including appropriate records for audit purposes

· Clearly conveys details regarding learning need and planning towards key stakeholders and towards the Business/ Markets/ Functions

· Ensures effective compliance learning assessment and evaluation practices are implemented, and defines improvement initiatives accordingly (to monitor, steer and report on performance)

· Leads design decisions ensuring effective, efficient, consistent compliance learning intake in the area of Quality, Clinical and Regulatory compliance

· Leads internal capability-building initiatives, with a focus on performance consulting, quality assurance and best practices in learning design

· Overall shapes and steers Philips compliance learning standards and excellence in approaches, processes, quality, learning impact and record keeping

· Supports the management team in meeting Quality & Compliance objectives

You are a part of

As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaborates with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world

To succeed in this role, you should have the following skills and experience

  • 10+ years Medical Device Experience
  • Advanced degree is preferred
  • Experience in either Software Development, IT or Software Validation
  • Experience leading a team of professionals
  • Provides guidance/feedback with respect to applicable regulatory requirements and Philips HealthTech policies and procedures
  • Recommends and leads corrective and preventive actions (CAPAs) related to non-product SW system intended function
  • Uses personal expertise, unique knowledge, and skills to contribute to development of company objectives and principles and to achieve goals in creative, lean and effective ways
  • Participate in the development of new strategies, concepts or processes. Frequently interacts with executives
  • Interactions frequently involve special skills, such as negotiating with management or attempting to influence senior level leaders regarding matters of significance to the organization
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people
  • Ensures budgets and schedules meet corporate requirements
  • Maintains, implements, and runs a compliant and effective SW Validation team of SQAs and SMEs for the programs and projects in scope
  • Maintain an effective and lean team of resources by analyzing demand and using the most appropriate resource-sourcing model
  • Support internal and external audits ensuring planning and schedule meets the requirements of internal policies and external regulations
  • Maintain status of applications, suppliers, projects and project releases in-scope for internal departmental reporting
  • Contributes to SDLM learnings and best practices to advance departmental methods
  • Provide timely escalation to upper management of confirmed validation issues such as improper planning, scope change, mitigated risks, staffing or execution of validation activities, resistance in adhering to the validation process, or decisions leading to compliance risks not consistent with the company risk strategy

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran

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

PI112225348

Industries

Posted: 2019-07-23 Expires: 2019-08-22

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Quality & Regulatory Competency & Education Director

Philips Electronics North America Corp
Boston

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