Ref No.

PM-21-74

Location

US ~ Garnet Valley, PA

Director, Project Management

Company Overview

Our growing and successful business comprises of over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

The Role

  • Responsible for leading an operational cross functional team which is responsible for delivering a portfolio of projects for a variety of customers. To ensure excellence of service with customers across the projects as measured by KPIs.
  • Accountable for the day-to-day management and completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget.
  • To provide support and mentoring to project managers and coordinators in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget.
  • To comply and adhere to GXP guidelines and regulations as required of this role.

Main tasks and responsibilities will include:

  • Oversee and maintain KPIs for the operational team to manage team performance
  • Attend planning meetings to discuss risks and issues to ensure customer programs are managed effectively
  • Ensure change order logs are maintained for the team
  • Oversee revenue forecasting, invoicing and debtor management for the team
  • Oversee scheduling of team portfolio to ensure the efficient resource utilization
  • Act as Program Manager for cross-site and Translational Pharmaceutics projects requiring a program manager, to drive one business one customer experience
  • Ensure color team members are adhering to the PM and team SOPs ensuring consistency of process
  • Point of escalation for issues within the assigned color team
  • Ensure all PMs in the team are trained for the tasks they are completing and are working to the Quotient quality system
  • Ensure all Gantts are kept up to date and EPM reports effectively reflect the color team portfolio
  • Prepare color team dashboards for color team meetings every 2 months
  • Ensure color teams are high performing teams – learning and developing to drive continual improvement to our busines
  • Ensure all PMs in the team are trained for the tasks they are completing and are working to the Quotient quality system
  • Support PMs in the team to lead the internal project team to ensure timely project communication and delivery throughout the life of the projects
  • Monitoring and control of allocated project progress to time/quality/cost
  • Support the PM with management of third party and internal suppliers as required
  • Generation, review and approval of appropriate project-related documentation and reports in line with SOP requirements
  • Support the PM with lessons learned meetings as appropriate
  • Support the PMs to ensure studies have appropriate mitigation strategies for project specific risks
  • Support other aspects of the business as needed

Additional Tasks/responsibilities

  • Manage large or high-profile customers, and internal and external stakeholders
  • Primary contact with the customer from project initiation to operational close out.
  • Host/chair customers meetings/teleconferences, take meeting minutes, and update technical teams accordingly based on meeting discussions
  • Act as liaison between technical groups, business development, and customer teams to ensure proper execution of proposals in customer required timelines
  • Manage project scope changes including timeline updates and costing
  • Develop and maintain risk register, issue log, and KPI for active projects
  • Monitor time, cost, and quality during project execution with budget responsibility
  • Track metrics related to project execution and assist in the development and execution of process and performance improvement initiatives.
  • Maintain knowledge of and compliance with the following regulations:
    • All appropriate state and federal regulations and guidelines
    • US FDA, European Health Authorities, Japanese Health Authority and other international authorities as needed
  • Work with outside vendors as necessary to facilitate project timelines

Job Demands

The job may involve the following:

  • Very high concentration of work
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Working in a hazardous environment and to follow safety procedures
  • Working outside normal working hours
  • Needing to respond to client demands

The Candidate

  • Minimum bachelor’s degree in science or engineering, or in a non-science area with relevant experience
  • At least 6 years project management experience working in a clinical research, pharmaceutical development, or GMP manufacturing environment
  • Ability to lead a multi-functional team
  • Experience managing direct-reports
  • Experience working in a contract development or contract manufacturing environment an advantage

Company Benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.