In this role, you have the opportunity to
Lead PD PQMS Quality organization to support the transformation activities of the Cluster Precision Diagnostic (PD). This is a key leader that is responsible for providing strategic and direction, in Philips quality management system (PQMS)
You are responsible for
Leading and transforming Precision Diagnosis sites by effectively establishing Philips QMS standards, QMS processes, and Philips Integrated Landscape (PIL) IT tools
Being a role model Change Manager to establish PQMS through close collaboration with many partners to influence lead Philips strategy of standardizing QMS processes in Precision Diagnosis sites.
Maintaining, enforcing, and managing a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels of HT.
Working closely with Precision Diagnostics PQMS and Q&R Leaders to provide consistent direction and mentorship to ensure a standardized and integrated approach to PQMS deployment and maintenance across the sector.
You will work closely with site Q&R leaders and other key partners to ensure all sites fully align with local and international standards as part of QMS processes such as 21 CFR Part 820, ISO 13485, ISO 9001, EU-MDR and other relevant regulatory/global standards suitable for their processes within their sites.
Ensuring proper audit planning and schedule meets the requirements of internal policies and external regulations.
Establishing and executing a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the QMS.
Driving effective and timely resolution to all audit non-conformances including internal, Philips Group and external. When necessary, you will partner with local manufacturing sites and Philips group level compliance team to support creation/submission/closure of responses to FDA/Competent Authority observations to ensure a positive outcome for company.
Leading level 1 audit program for PD sites as necessary
Acting as a transformation agent to drive compliance and accountability to Philips Quality Key Performance Indicators.
Working with various Q&R leaders to establish standard reporting tools to provide daily, weekly, monthly reports and updates to PD Leadership Team.
You are a part of
In this role you will provide E2E QMS Leadership for the Business Cluster Precision Diagnosis. The business spans across several sites and covers 6 Businesses. The purpose of the role is to define the quality strategy for QMS across cluster closely collaborating with relevant business partners and Q&R leaders and stakeholders. Collaborates closely with the Head of Q&R Cluster PD. This is a change agent role that enable cluster business collaborate and deliver PD solutions that meet the quadruple aim
To succeed in this role, you should have the following skills and experience
Degree in a Life Science or Engineering, a secondary business or management degree would be a distinct advantage
Preferred 10 years in a Medical Device or Pharma Regulated environment
Fair understanding of global regulatory landscape is required with keen understanding of patient safety and product quality dedications
Leadership experience in various aspects of Q&R and preferably in at least one operating Quality process domain preferably QMS
Familiar with business process management frameworks include the best industry practices as it pertains to QMS
Experience in change management is required.
Relevant training, experience and certification in Continuous Improvement practices such as Lean/ Six Sigma highly preferred
Business Insight and strong Business Partnering Skills is a distinct advantage
Highly collaborative influencer who is an effective communicator and relation builder/ networker
Willing to travel up to 40 %
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .