QMS and Document Control Manager (Freelance)

As a QMS and Document Control Manager within the PQMS Markets Central Team reporting to the Snr QMS Manager (Change Management and Document Management), you will ensure Philips Markets and QMS documentation and records are compliant with Good Documentation Practices, and highest Quality Standards (Philips and industry).
You will guide and support the Deployment Leads, Markets and Global Business Services functions to always do the right thing.

Your challenge will be to support the deployment an implementation of Philips standardised processes across all Markets into the Markets Quality Management Systems (QMS).

• Provide guidance on documentation structure and format to ensure compliance to procedures, relevant regulations, and standards.
• Review and assess all QMS procedures and Quality documentation and records for accurate format, signatures, dating and for compliance with against Good Documentation Practices (GDP); and act upon assessment outcomes.
• Manage QMS procedures and Quality documentation and records across the end-to-end document life cycle - to maintain consistency to customer requirements, enterprise and local procedures and changes or improvements to site processes
• Assist and support the Change Control requests for new/revised controlled documents
• Assist and support the researching and reviewing each Change Control request for adequacy and accuracy.
• Develop and maintain quality related metric dashboards including but not limited to, daily management, CAPAs, audit findings, issue reviews, and others
• Define, monitor, track, and report on documentation metrics (e.g., documentation release rates, documentation rejection and adoption rates, etc.
• Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities
• Assist the PQMS Deployment Lead in resolving process or procedural related problems.
• Drive solutions to ensure internal customer related problems/issues are communicated and manage at first time right
• Establish routine communication strategies for project tracking and prioritizatio
• Drive continuous improvement for practices in scope
• Timely escalate quality related issues to ensure effective and timely remediation
• Support and execute on Quality Transitions Plan and improvement initiatives and projects for all activities in scope
  
   

To succeed in this role, you need to be a person who is excited by the unique professional challenges that our Quality Transformation presents, with the right quality, customer service and team player mindset. We?re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people our brand touches each year.

You should have the following skills and experience:

• At least 3 years' experience with GDP and Document Control Practices within a worldwide highly regulated industry such as Medical Device or Pharma, Automotive, Food and Beverage, Cosmetics Industry.
• At least 2 years' experience with QMS Compliance within a worldwide highly regulated industry such as Medical Device or Pharma, Automotive, Food and Beverage, Cosmetics Industry.
• Understanding of ISO 9001:2015, ISO 13485:2016 and 21 CFR 820.
• Professional written and oral communication skills across all levels of the organization
• Accurate, superior planning, problem-solving and trouble-shooting skills with attention to detail and follow-through.
• Able to resolve issues proactively and independently in creative ways
• Project management experience
• Flexible in working hours due to the regional/global scop
• A hands-on mentality
• Self-Starter and taking ownership mentality
• Full proficiency of the English language; native French or German speaking is a plus