Our client, a world leader in Pharmaceuticals and In- Vitro Diagnostics (IVD) tools,is looking for Product Owner/Manager - Post Market Quality(100% Remote).
Job Title: Product Owner/Manager - Post Market Quality(100% Remote)
Job Duration: Long Term Contract (Possibility Of Further Extension) on W2
Responsibilities:
- You are accountable for the global alignment between the Quality Management System (QMS) framework and the Post Market Quality (PMQ) tool Ensuring that the PMQ tools support the modular framework and are compliant with applicable and regional regulatory ;
- Influencing Senior Leaders such as General Managers and Regional Managers acceptance and adoption of the global PMQ ;
- You are a strong matrix leader who is ready to enthusiastically partner with our sites, Affiliates, and IT to ensure that our tools meet requirements and our right to operate and help us create ;
- Responsible for the health of Post Market Quality System Applications in terms of quality and operational effectiveness from a functional and technical ;
- Provide SAFe Agile execution of the enterprise-wide PMQ Understands business needs and priorities, uses multiple sources of information including broader stakeholder views to develop solutions and recommendations by bringing an end-to-end process ;
- There is a key focus on managing the relationship with the business at both a strategic and portfolio level to ensure the IT organization has early insight into changing business directions in order to inform and shape IT
Education / Experience / Skills :
- Bachelor s / Master degree in Life Science, Pharmacy or related subject
- At least eight (8) years of IT experience within Quality and Regulatory focusing on PostMarket Quality or equivalent experience and demonstrated knowledge of PMQ
- Salesforce, Trackwise (Honeywell), Smarteeva applications
- Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) processexperience
- At least ten (10) years in the Medical Device/Pharma/Biopharmaceutical industry with 5years working in Quality, Compliance, Regulatory and/or Validation, preferred orequivalent
- Excellent knowledge of the European, US, China and International cGMP regulationsand demonstrated ability to adequately interpret and implement quality
If interested, please send your updated resume at.
SAP MDG, SAP ECC / S/4 HANA, SAP Information steward, SAP MDQ