Director Project Management

Our client a well-known Contract Packager of Pharmaceutical Products seeks a Director Project Management to manage a direct team of 10 people.

Position Overview

The Director of Project Management position provides primary leadership for new products/projects and externally driven changes to existing products.  The position oversees all marketing and product management functions such as project management for customer focused projects, ensuring product management compliance to ISO and FDA regulations, advertising, website management, market research and supervision, development and growth of the Project Management Team.  The position is also responsible for capacity planning.  This position reports to the V.P. of Project Management.

Position Responsibilities

• Coordinate all internal project efforts either directly or by supervision of the product management team.
  • Determine feasibility and cost effectiveness of all new customer driven projects and internal cost productivity projects.
    • Determine AQL basis for costing purposes
    • Develop product launch costs including above standard labor and materials
    • Reconcile actual costs versus plan after product launch
  • Utilize appropriate software such as Microsoft Outlook, Excel, and Microsoft Project to coordinate complex projects and keep all stakeholders informed.
    • Communicate directly with customer representatives as needed and appropriate.
  • Work with Executive VP of Sales, Account Managers & Sales Coordinators to ensure all customer requirements are understood and that all applicable internal customer action items are managed.
  • Generate and coordinate Process Scale-Up Protocols for, product development, product changes and feasibility studies.
  • Ensure timely and accurate generation of Product Master Records, Master Batch Records and related documents to allow for sourcing of components and startup of production as agreed to within and outside the organization.
  • Work with manufacturing, purchasing, quality, laboratory, and engineering departments to ensure smooth launch of new products/projects.
    • Work with Manufacturing and Engineering groups on process developments and changes driven by external needs
    • Ensure compliance to Design Control process through communications with Quality
    • Communicate sourcing needs to Purchasing Group to ensure timely and cost-effective sources for components
    • Responsible for ensuring MRP tools are used in a timely and appropriate manner for new projects.
  • Ensure Sales Staff receives technical support as needed.

• Staff, train, develop and manage a Project Management Team to support business plan objectives.
  • Determine and communicate staffing needs to meet business growth objectives.
  • Ensure all team members are trained and have an ongoing training plan to handle their functions. All team members must understand and follow appropriate procedures and work instructions.
  • Develop annual goals for team members and assess performance versus goals.
  • Work with team members to develop career paths as appropriate
  • Provide team members access to the contract packaging market through customer contact and trade show and conference attendance.

• Other responsibilities.
  • Responsible for driving product-related cost productivity programs.
  • Responsible for maintenance of product cost standards
    • Review and update all standard costs on a quarterly schedule
  • Participate on various corporate teams as needed and assigned.
  • Work with Leadership Team during Business Planning process as requested.
  • Work directly with customers as needed to ensure successful implementation of plans and projects.
  • Assist CP sales team with trade shows, conferences and customer presentations as needed.

Key Skills & Experiences Required

• Product Management experience in FDA regulated products and/or services.
• Experience managing complex projects in an FDA regulated environment.
• Strong team player.
• Direct or indirect sales/marketing experience with value-added products and/or services.
• Direct experience and demonstrated success in relationship management in a matrix organization.
  • Proficiency in conflict management.
• Ability to manage multiple priorities.
• Experience in product costing, product placement and distribution channels.
• Proficiency in Microsoft Office Products, Microsoft SharePoint and Microsoft Project.
• Ability to develop and make effective presentations to management and customers.
• Understand the nuances of matching customer requirements with manufacturing and service capability.
• Strong analytical and technical skills.
• High level of curiosity and desire to learn.
• High level of credibility and integrity.

Education/Experience

• Undergraduate Degree in technical or business field required, engineering degree preferred.
• Master’s degree or equivalent experience preferred.
• Experience in pharma / FDA regulated industry required
• Knowledge of new product development processes and tools desired.