The Program Director is responsible for directing very high complexity matrixed teams to deliver high visibility, strategic programs and company-wide initiatives.  Typically manages a portfolio of multiple programs and/or projects across multi-disciplinary teams.  Programs are normally very high complexity considering total cost, financial impact, systems impacted, performing labs, software development, test complexity and outside entities/third parties.

The Program Director reports to the SVP, Chief Quality & Regulatory Affairs Officer and part of the Q&RA Leadership Team. As a cross-functional leader, the role consults with Quality & Regulatory Affairs, Research & Development, Product Development, IT, and Lab Operations organizations to guide the successful development and implementation of the organizational, operational and technical solutions needed to sustain a robust global Quality Management System.

The Program Director provides comprehensive written and verbal status updates to C-suite leadership, senior leadership, executive/program sponsor and key stakeholders for key strategic programs. Understanding and experience with FDA quality and regulatory terminology related to all phases of medical device design development and post-market surveillance is critical to the success of the role.

The Program Director is also responsible for driving broad cross-functional process improvement initiatives, as well as ensuring best practices are utilized throughout planning and execution management. This individual is expected to apply continuous improvement tools and techniques towards a variety of large or complex problems.

• Responsible for program performance, risk management, administration and issue resolution for the functional team. Develop quality assurance and control plans where indicated.
• Directs programs and cross functional working teams to effectively initiate, plan, execute, monitor and close projects. Acts as the primary liaison at the project and program level for all related information.
• Develops and executes project plans, milestone charts, project/program documentation and scorecards according to requirements defined and approved by sponsor.
• Facilitates high profile large scale intra- and inter-organizational meetings, workshops and targeted events to help teams quickly achieve strategic objectives.
• Manages project deliverables in accordance with approved schedules. Analyzes critical path, proactively identifying issues and raising/facilitating resolution with cross-functional team. Drives visibility to gaps impacting overall schedule. Synchronize projects at program level to optimize delivery. Drive visibility to critical path and gaps impacting overall schedule. Drive roadblocks to resolution.
• Manages executive/program sponsor and stakeholder expectations and establishes regular points of communication.
• Manages changes to project and or program scope, cost and schedule via formal change management process.
• Proactively identifies and manages project/program risks. Directs team members, key stakeholders and sponsors through roadblocks/barriers to resolution.
• Performs root cause analysis using Continuous Improvement tools (e.g., 5 whys, lessons learned) at project and program level. Documents and communicates project shortfalls. Drives corrective action, analyzing at the project level, trending across projects/programs (people, process, system).
• Acts as a change agent to drive key stakeholders, project/program sponsor and leadership toward success.
• Tracks cost, budget, resources, plan and schedules and manage changes at program level as appropriate. Ensures project artifacts are collected, documented and stored for audit and lessons learned purposes.
• Direct external vendors as indicated to plan and execute program requirements. Acts as liaison for all program related communications and status updates.
• Leads cross-functional efforts to develop and communicate business process documentation where absent/improvements needed to drive successful project/program planning and execution.
• Understands strategic business direction with respect to portfolio/sub-portfolio and can prioritize initiatives and control program execution.
• Up to 25% travel.
• May manage direct reports
  • Participate in the hiring of new resources.
  • Coaches and counsels direct reports.
  • Provides counseling related to career path to direct reports.
  • Guides direct reports in developing personal learning plans.
  • Supports skill development of direct reports.
  • Participates in performance review and feedback process.

Helps resolve performance issues for direct reports.

• Bachelor’s Degree required (BS/BA).
• PMP Certified Project Management, Certified Program Management Professional (externally administered by the Project Management Institute) strongly preferred.
• Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean) a plus.
• Demonstrated experience leading projects/programs from initiation to completion in a matrixed organization (10+ years’ experience).
• Experience driving Quality Management System directives in the Health Care Sector a plus.
• Experience in FDA regulated, medical devices settings preferred.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets