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Program Manager

ASG offers careers in program management. Big-picture thinking and attention to detail are equally important to program managers, who articulate strategy and objectives, support technical teams and ensure we meet the goals of our clients in regulated industries, especially the pharmaceutical and medical device industries.

Description

The role of the program manager is to work within a cross-functional organization to use technologies and methodologies that support the robust design of development and manufacturing in regulated industries — often in the pharmaceutical and medical device industries.

Program managers often participate in project team meetings and one-on-one interactions with project team members. They work closely with team members to develop detailed engineering specifications. They also support design and development of devices, as well as verification, validation and clinical manufacturing. After a product launches, they help manage post-launch feedback and complaints.

Program managers also:

  • Work collaboratively with others to understand team dynamics and be able to assemble, lead and motivate effective teams at all levels of the organization
  • Develop, execute and review architecture documents, design documents, specifications, development plans, verification and validation plans and other related product development documents for assigned projects
  • Work with quality engineers and complaint managers to assess and take care of device complaints, including root cause analysis, with tight timeline requirements

Technical skill requirements

  • Technical decision-making and issue resolution
  • Design of equipment for purposes of Good Manufacturing Practices
  • Understanding of high-speed automation
  • Experience with quality systems, including ISO or related compliance regulations and management of engineering development procedures
  • Experience in interacting with regulatory agencies
  • Knowledge of design controls: specifically product design and enhancements
  • Strong problem-solving, risk assessment and risk management skills
  • Strong verbal and written communication skills
  • Able to analyze problems, apply critical thinking and find creative solutions
  • A solid history of meeting and exceeding expected results in past positions
  • Must be capable of working on multiple projects in a deadline-driven environment
  • Must be able to maintain confidentiality of information and practices while finding solutions to meet project needs

Nontechnical skill requirements

In addition to having strong verbal and written communication skills, program managers must have the ability to:

  • Understand and define the scope of work for engagement
  • Manage resource assignment and balance workload
  • Be self-motivated, have a bias for action, a sense of urgency, and quickly take personal responsibility to drive improvements
  • Balance multiple projects, teams and demands daily
  • Support remote assignments (3-6 months) working at the facilities of equipment vendors or contract manufacturers

Education and experience

  • Bachelor’s degree in technical field or equivalent experience
  • PMP or equivalent preferred but not required
My role is to keep everybody on the same page and make sure we’re hitting deliverable dates when we’re supposed to hit them. It’s a lot about communicating — connecting the dots and making sure we’re getting things done to reach our goals.

Jason Schnaus, Program Manager

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