Head of NPSS Business & Legacy Remediation

Job Title

Job Description

In this role you have the opportunity to

Senior manager interfacing across the business and market Q&R teams to execute on software validation initiatives. This position manages the validation health for a portfolio of software tools used to automate quality system decisions in use across multiple businesses. This position also maintains the inventory of SVAL Q&R tools used within this functional group and monitors their validation status

You are responsible for

• Manage a team of validation professionals to execute and consult on software validation activities in accordance with software development lifecycle policies and procedures.
• Support development of the validation strategy and the validation effort of Business Applications / Legacy Remediation systems.
• Support regulatory and internal audits when required. - Provide subject matter expertise during regulatory and partner inspections.
• Ensure that Multi-BG system development projects and changes to existing systems are conducted in compliance with the FDA Quality system Regulation and Medical Device Directives.
• Participate in the development definition and enforcement of departmental policies and practices.
• Provide guidance and Support to personnel in their validation efforts to ensure compliance.
• Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
• Establishes effective communication with other functional groups and key stakeholders.
• Assist in development maintenance reporting and analysis of key performance indicators as assigned including trending target setting ensuring initiation of corrective actions and records.
• Partner with business Q&R software validation teams to support their understanding of software validation requirements and monitor achievement of Q&R objectives

You are a part of

As a result of Philips renewed commitment to Quality it has recently restructured its organization to ensure you and your department have clear interfaces 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 experience in software validation preferably in the medical device industry
• 5 years experience leading a team
• Bachelors Degree required preferably in an engineering discipline; Masters Degree preferred
• Assist in development maintenance reporting and analysis of key performance indicators as assigned including trending target setting ensuring initiation of corrective actions and records.
• Partner with business Q&R software validation teams to support their understanding of software validation requirements and monitor achievement of Q&R objectives

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. Its 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 its 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 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 option 5 for assistance.

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