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Regulatory Affairs Program Manager

2 months ago

Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Program Manager to join our team at Werfen. As a key member of our organization, you will be responsible for planning and managing quality and regulatory projects across multiple phases within a large multifunctional compliance program.

Key Responsibilities:

  • Provide technical and team leadership to one or more small project teams or a program team, including planning, scheduling, and technical leadership within the program area.
  • Responsible for project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates.
  • Responsible for conducting regular project or program team status meetings and reviews, ensuring deliverables are completed and documented, and identifying the need for and implementing changes to the project plan that are within approved project boundaries.
  • Coordinate project resources to identify the root cause(s) of project issues, develop and manage a plan to fix, test, and implement an appropriate solution through completion.
  • Ensure program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan.
  • Responsible for program communication within the project team(s), between team(s), and to executive management.
  • Coordinate discussions with commercial functions (operations, R&D, distribution, customer support, marketing, sales, service, affiliates, etc.) through established communication channels to support quality, regulatory, or compliance initiatives.

Requirements:

  • Bachelor's degree or higher in a relevant degree; a business, technical, or project management degree is preferred.
  • Minimum of 10 years in a project management role, or 7 years with an advanced degree.
  • Professional certification in project management or program management is desired.
  • Familiarity with quality and/or regulatory project environments preferred.

Skills and Capabilities:

  • Leadership skills.
  • Problem-solving, conflict management, listening, managing and measuring work.
  • Strong project management skill set and familiarity with project management tools and techniques.
  • Team player, self-motivated, perseverance.
  • Strong oral and written skills.
  • Fluent with MS Word, Excel, PowerPoint, & Project.
  • Significant experience with project management approaches and concepts as well as some experience working across multiple project efforts.

Travel Requirements:

Less than 10% of the time.