Quality Project Lead, Portfolio Optimization

Salary depends on experience
Posted on 02/19/18
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 02/19/18

Responsibilities will include:

  • Engagement and project management of all franchise quality project resources (post market surveillance, customer quality, records management, document management, etc.)
  • Implementation and continuous improvement of DePuy Synthes process for product discontinuation
  • Mentoring and ensuring compliant implementation of quality and cross-function team members for the product discontinuation process
  • Documentation of quality activities related to product discontinuation
  • Partner with cross-functional project team members, such as commercial, research and development, supply chain, regulatory affairs to ensure all identification of interdependencies and appropriate risk mitigations
  • Provide leader to Quality partners across up DePuy Synthes for executing product discontinuation activities
  • Manage detailed quality plans for all quality operations discontinuation activities
  • Ensure effective and efficient use of Quality Engineering resources across sites / regions for execution of discontinuation efforts
  • Provide guidance and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.)

Position duties & responsibilities:

  • Lead transactional lean projects associated with Quality Processes
  • Identify process improvement opportunities that will results in target efficiency thresholds
  • Collaborate and partner with decision makers across multiple functions and sites
  • Follows and observes all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
  • Follow J&J Safety Requirement and safe working conditions and practices in the department.
  • Additional responsibilities may be delegated as project needs require. 

Qualifications

  • A minimum of a Bachelors degree is required in an Engineering or Science discipline.
  • Minimum of 7 years overall business experience in a highly regulated business environment.
  • Experience in highly regulated manufacturing environment is preferred
  • Minimum of 1 year of Project Management experience is required, along with demonstrated cross functional business acumen
  • .
  • Able to deliver oral and written communications around process improvement projects that have transparency and impact.
  • Organized, analytical approach to problem solving. Familiar with FDA, GMP and ISO requirements. Strong computer skills – Microsoft Office, Visio. Working knowledge and proven ability in project management.
  • Ability to audit business processes to identify non-compliance to requirements and develop/oversee action plans for corrective action.
  • Ability to understand and translate customer needs and insights (Explicit and Implied);
  • Ability to develop and implement customer Facing Metric Development
  • Required to travel up to 10% as project needs may call for.

Requisition ID: 9482180112

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