Project Manager

Quality Project Manager is responsible for leading cross functional project teams focused on the quality of products, systems, and operations. This includes coordination with corporate and divisional quality, development, and regulatory teams with new product launches, technology transfers, and equipment/facility changes. This role is responsible for coordinating activities to complete quality plans, CAPA, and site-specific projects. Additionally, this person will manage the quality metrics dashboard and resource availability and timelines. As Quality Project Manager this person is responsible to make decisions on project direction and timelines.

Primary responsibilities are to:

30% Lead cross-functional team in a matrix environment

Independently lead projects with limited direction

Must be able to Influence others beyond their scope and level

20% Develop and manage project plans and schedules

Utilization of tools to identify, manage and communicate processes and risk

Drive team accountability for deliverables and ensure projects meet milestones.

Develop agendas, minutes, metrics, etc. for the teams. Make timely updates to Project Templates and Project Dashboards.

20% Drive the team to deliver results/conclusions, manage conflicts, and deliver solutions

Timely and effective verbal and written communication to teams and stakeholders

Provide ongoing status communication to the team and appropriate levels of the organization

10% Identify issues and opportunities, developing and delivering viable alternatives and contingency plans, engaging teams in healthy debate/conflict, communicating risk and developing proposed mitigation plans

10% Lead prioritization exercises with teams. Escalate risks and issues to relevant stakeholders. Lead delivery of tactical and achievable mitigation & contingency planning.

10% Lead "lessons learned" exercises, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates.

DESIRED MINIMUM QUALIFICATIONS

Education: A Bachelor's Degree is required, with degree in Physical Sciences, Business or a related discipline preferred

Strong understanding of 21 CFR, ICH Q7-010, E6 and IS013485

Certifications: PMP, Process Excellence, or Six Sigma certification preferred

Experience: Minimum 5 years of relevant project management experience with increasing responsibility in the medical device, pharmaceutical, or related regulated industry is required.

Excellent oral, written and presentation communication skills are required.

A proven record of leading teams in a matrix environment to deliver results is required

Familiarity with standard PM tools and templates is required

Business and Financial acumen is required.

Demonstrated leadership and influencing skills are required.