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DIA Product Manager Post Market Quality

Indianapolis, IN 46256

Posted: 05/16/2023 Employment Type: Contract Industry: Medical Affairs Job Number: 11245 Pay Rate: $64.00 - $132.00

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Position Description:

As a Global Quality & Regulatory Post Market Quality Product Owner, you are accountable for the global alignment between the Quality Management System (QMS) framework and the Post Market Quality (PMQ) tool landscape. Ensuring that the PMQ tools support the modular framework and are compliant with applicable and regional regulatory requirements. Influencing Senior Leaders such as General Managers and Regional Managers' acceptance and adoption of the global PMQ tools. 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 value.

  •  Drive business results and customer value
  •  Responsible for the health of Post Market Quality System Applications in terms of quality and operational effectiveness from a functional and technical perspective.
  • Provide SAFe Agile execution of the enterprise-wide PMQ tools.
  • 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 approach. This requires ongoing, proactive interaction with cross-functional users while providing consistent communication with various functions.
  • 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 demand.
  • Acts as a product owner and works closely with IT, PMQ SMEs, and other applicable stakeholders in the planning and design of application implementations, changes and coordinating on delivery and deployment processes.
  • As an evangelist, this position stays abreast of functional and development tools, trends, and practices that should be considered for future initiatives.
  • Develops deep business and application domain knowledge for the PMQ business portfolio to aid in critically evaluating the balance of both business needs and user requests.
  • Globally influence the acceptance and realization of the PMQ tools across all Diagnostics Sites & Affiliates, ensuring the QMS tool delivers on the objectives as an enabler to the Diagnostics 10 year Strategy.
  • Accountable to ensure that our tools meet Health Authority regulations, Notified Body requirements, Company standards and expectations throughout the global organization including operations, development, and affiliate sites.
  • Provide matrix leadership and guidance to staff executing Quality Management System functions and adoption of the PMQ tools.
  • Assume the role of Source Data Product Owner; ensuring transactional data is FAIR (findable, accessible, interoperable, reusable) and consumable within global data warehouse (snowflake).
  • Curating Post Market Quality data and participating in Data Squads to ensure PMQ data is easily interpreted and consumable.
  • Analyzes business and user needs, establishes clear business value objectives, documents requirements, and revise existing system logic or business process difficulties to select, build or modify large, complex or mission critical information systems to achieve business value
  • Adds value to the delivery team by working with the business and product owner to create clarity around business objectives through the development of and refinement of user stories
  • Lead, coach, and guide the organization.
  • Be the champion and advocate for Engrained Quality globally.
  • Build a culture of continuous improvement and model matrix leadership principles.
  • Enable the organizations New Ways of Working
  • Act as role model for Agile Matrix Leadership behaviors, as well as for our culture, mindset & behaviors
  • Model behaviors to support the organizations transformation to new, more Agile Ways of Working.
  • At least eight (8) years of IT experience within Quality and Regulatory focusing on Post Market Quality or equivalent experience and demonstrated knowledge of PMQ processes
  • Salesfore, Trackwise (Honeywell), Smarteeva applications Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) process experience
  • At least ten (10) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience.
  • Bachelors / Master degree in Life Science, Pharmacy or related subject. Advanced degree is considered an advantage.
  • Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards.

Meet Your Recruiter

Jay Hite
Recruiter, Account Manager

As a Recruiter at Compass, Jay enjoys meeting job seekers and helping them to find new and exciting opportunities. He enjoys the process of getting to know candidates and learning all about their experience and what their future goals are. Jay feels the excitement of his candidates and is passionate about helping to find a fit both culturally and professionally. 

When Jay isn’t working, he enjoys bike rides, trying out new foods, tequila tasting and watching movies.  

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