Philips Senior Manager, Quality & Regulatory in Singapore, Singapore

This is a Singapore based role, with a large percentage of time spent in our Batam manufacturing site.

In this role, you have the opportunity to

This key manager role is responsible for providing strategic and transformational direction, and operational leadership to establish Philips quality management system (PQMS) for Operations at manufacturing site level. This role will partner with site-level Quality & Regulatory leader, various Operations/supply chain stake holders including but not limited to Operations, Procurement, IT, Manufacturing at the site level to drive Philip standard processes and continuous compliance. In addition, this role will help establish Batam manufacturing site as a medical device-manufacturing site that is successfully certified to ISO13485, MDSAP and 21CFR820 requirements.

This manager will work closely with Health & Wellness (H&W) and Domestic Appliances (DA) site-level operations and Q&R teams in strategizing, planning, and deploying standardized QMS processes across various processes at the site including, but not limited to, Change Control, Document Management, Non-product software tools, CAPA, internal and external auditing, Management Controls, and data analysis.

You are responsible for:

  • Accountable for leading and transforming Batam site by effectively establishing Philips QMS standards, QMS processes, and Philips Integrated Landscape (PIL) IT tools

  • Act as a role model Change Manager to establish PQMS through close collaboration with many stakeholders to influence manage Philips strategy of standardizing QMS processes in Batam.

  • While working closely with manufacturing site Q&R leader and other key stakeholders, shall ensure Batam site is fully complying 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 that site.

  • Works closely with Operations Q&R to deploy a network of Operations QMS process BPEs/SMEs to ensure effective implementation and transformation of Philips QMS strategy and continued compliance to QMS processes.

  • When required drive effective and timely resolution to all audit non-conformances including internal, Philips Group and external.When necessary, will be required to collaborate with other manufacturing sites and Philips group level compliance team to support creation/submission/closure of responses to FDA/Competent Authority observations to result in a positive outcome for the site.

  • Collaborating closely with site level leadership to develop best in class auditing controls with supplier base to ensure effective alignment to downstream supply chain.

  • Act as a transformation agent to drive compliance and accountability to Philips Quality & Regulatory Key Performance Indicators (KPI).

  • Registers the Batam site with US FDA and drives towards successful ISO13485 and MDSAP certification working with competent authority /notified body.

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

  • Bachelor’s degree with at least 8 – 12 years of industry experience, in a highly regulated environment of Medical Devices, Automotive, Aerospace, etc., with at least 3 years of site-level leadership experience.

  • Must be experienced in establishing site level QMS strategy & oversight in a global company.

  • Must demonstrate critical understanding and experience in product design, manufacturing and distribution principles/environment while working with class I medical devices and high volume units.Experience within consumer goods and electronics is a plus.

  • Must have solid root cause hands-on experience to resolve timely issues and improvements.

  • Must have demonstrated by leading and implementing site-level QMS processes resulting in standardizing and improving way of working and providing agile and efficient process.Such tools and processes can be but are not limited to Change Control/Document Control, Non-product Software tools, Training tools, Auditing process, non-conformance process such as CAPA program and Complaint Management Process.

  • Working in remediation/transformation environments is required in order to ensure as a leader the individual can deliver on continuous improvements across various quality and non-quality type processes.

  • Must possess good experience managing and/or facilitating FDA, competent authorities, and Notified Body audits and inspections with favorable outcomes.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based 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.

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 .

At Philips, we believe there’s always a way to make life better. We innovate for people and for our people. By joining Philips, you will have the opportunity to make an impact on helping to improve lives. We also believe that we are strong only when you are. That is why we offer a variety of innovative benefits, flexibility and health programs aimed at helping you be at your best. The cutting edge challenges, inspiring teams, learning resources and unexpected career experiences will equip you to be in full control of your desired career.

To find out more about what it’s like working for Philips, visit the Working at Philips page at https://www.philips.com/a-w/asiapac/careers/healthtech/working-at-philips/working-at-philips.html on our career website and read about what our people say at https://www.philips.com/a-w/asiapac/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at https://www.philips.com/a-w/asiapac/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Follow us on LinkedIn at https://www.linkedin.com/company/1090/life/ for updates on industry news.

This is a Singapore based role, with a large percentage of time spent in our Batam manufacturing site.

In this role, you have the opportunity to

This key manager role is responsible for providing strategic and transformational direction, and operational leadership to establish Philips quality management system (PQMS) for Operations at manufacturing site level. This role will partner with site-level Quality & Regulatory leader, various Operations/supply chain stake holders including but not limited to Operations, Procurement, IT, Manufacturing at the site level to drive Philip standard processes and continuous compliance. In addition, this role will help establish Batam manufacturing site as a medical device-manufacturing site that is successfully certified to ISO13485, MDSAP and 21CFR820 requirements.

This manager will work closely with Health & Wellness (H&W) and Domestic Appliances (DA) site-level operations and Q&R teams in strategizing, planning, and deploying standardized QMS processes across various processes at the site including, but not limited to, Change Control, Document Management, Non-product software tools, CAPA, internal and external auditing, Management Controls, and data analysis.

You are responsible for:

  • Accountable for leading and transforming Batam site by effectively establishing Philips QMS standards, QMS processes, and Philips Integrated Landscape (PIL) IT tools

  • Act as a role model Change Manager to establish PQMS through close collaboration with many stakeholders to influence manage Philips strategy of standardizing QMS processes in Batam.

  • While working closely with manufacturing site Q&R leader and other key stakeholders, shall ensure Batam site is fully complying 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 that site.

  • Works closely with Operations Q&R to deploy a network of Operations QMS process BPEs/SMEs to ensure effective implementation and transformation of Philips QMS strategy and continued compliance to QMS processes.

  • When required drive effective and timely resolution to all audit non-conformances including internal, Philips Group and external.When necessary, will be required to collaborate with other manufacturing sites and Philips group level compliance team to support creation/submission/closure of responses to FDA/Competent Authority observations to result in a positive outcome for the site.

  • Collaborating closely with site level leadership to develop best in class auditing controls with supplier base to ensure effective alignment to downstream supply chain.

  • Act as a transformation agent to drive compliance and accountability to Philips Quality & Regulatory Key Performance Indicators (KPI).

  • Registers the Batam site with US FDA and drives towards successful ISO13485 and MDSAP certification working with competent authority /notified body.

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

  • Bachelor’s degree with at least 8 – 12 years of industry experience, in a highly regulated environment of Medical Devices, Automotive, Aerospace, etc., with at least 3 years of site-level leadership experience.

  • Must be experienced in establishing site level QMS strategy & oversight in a global company.

  • Must demonstrate critical understanding and experience in product design, manufacturing and distribution principles/environment while working with class I medical devices and high volume units.Experience within consumer goods and electronics is a plus.

  • Must have solid root cause hands-on experience to resolve timely issues and improvements.

  • Must have demonstrated by leading and implementing site-level QMS processes resulting in standardizing and improving way of working and providing agile and efficient process.Such tools and processes can be but are not limited to Change Control/Document Control, Non-product Software tools, Training tools, Auditing process, non-conformance process such as CAPA program and Complaint Management Process.

  • Working in remediation/transformation environments is required in order to ensure as a leader the individual can deliver on continuous improvements across various quality and non-quality type processes.

  • Must possess good experience managing and/or facilitating FDA, competent authorities, and Notified Body audits and inspections with favorable outcomes.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based 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.

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 .

At Philips, we believe there’s always a way to make life better. We innovate for people and for our people. By joining Philips, you will have the opportunity to make an impact on helping to improve lives. We also believe that we are strong only when you are. That is why we offer a variety of innovative benefits, flexibility and health programs aimed at helping you be at your best. The cutting edge challenges, inspiring teams, learning resources and unexpected career experiences will equip you to be in full control of your desired career.

To find out more about what it’s like working for Philips, visit the Working at Philips page at https://www.philips.com/a-w/asiapac/careers/healthtech/working-at-philips/working-at-philips.html on our career website and read about what our people say at https://www.philips.com/a-w/asiapac/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at https://www.philips.com/a-w/asiapac/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Follow us on LinkedIn at https://www.linkedin.com/company/1090/life/ for updates on industry news.