Senior Quality Assurance Project Manager

Recruiter
RBW Consulting Solutions Ltd
Location
Boston
Posted
06 Nov 2017
Closes
16 Nov 2017
Contract Type
Permanent
Hours
Full Time

Senior Quality Assurance Project Manager

Boston, MA

  • Provide cost/risk decision options in order to align project requests with overall business objectives.
  • Lead a project team to define clear organizational priority of the project requests
  • Define a cost and milestone timeline to assure success
  • Provide project reviews to senior management as needed
  • Lead cross-functional project teams through wide variety of project types.
  • Define project objectives, requirements and assumptions necessary to structure a project or activity.
  • Plan, schedule and control project activities to fulfil objectives and satisfy project requirements.
  • Develop and drive integrated project plans, aligning project tactics with project strategy.
  • Lead, coordinate, facilitate and motivate all associated project resources to gain alignment on project goals and deliverables.
  • Lead risk management within project teams, ensuring risks have appropriate mitigation and contingency plans.
  • Facilitate and lead effective project meetings, manage change and conflict and provide leadership to personnel assigned to projects.
  • Conduct knowledge transfer and training of end-users including sharing best practices.
  • Develop resources planning estimates to manage project workload and productivity.
  • Oversee all aspects of projects including but not limited to establishment of clear objectives, planning and scheduling, data trending and analysis, cost assessment, training, implementation, reporting, etc.
  • Be familiar with a variety concepts, practices and procedures across the entire organization in order to recognize how systems connect and affect one another.
  • Operate in accordance to established quality management system.
  • Maintain current knowledge of applicable domestic and international regulations.

Requirements

  • Bachelor's Degree in Engineering, Science, or other related field
  • 8 years of relevant work experience in a cGMP regulated pharmaceutical or medical device environment
  • 5 years of experience related to project management
  • Knowledge of FDA regulations as they pertain to Sage Products, specifically 21CFR211 and 21CFR820
  • Familiar with international standards and regulations as they pertain to Sage Products (i.e. MDD, ISO13485, etc.)
  • Exceptional interpersonal and leadership skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels.
  • Sound technical aptitude and proven ability to grasp general knowledge of multiple disciplines and technologies with superior computer usage skills.
  • Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
  • Experience in a cGMP regulated pharmaceutical or medical device environment required
  • Evidence in management of complex or high level projects
  • Graduate degree is a plus
  • Knowledge and application of a disciplined project management process (Six Sigma or Project Management Professional certification is a plus)

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn?t for you but you?d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!


This job was originally posted as www.jobsite.co.uk/job/959472980