Program Manager

3 weeks ago

Andover, United States NACS Full time

Job Description:

As a Program Manager, you must have a strong organizational and project-based background. You will serve as a direct contact for both internal employees and our customers, and be responsible for coordinating program activities, timelines, program budgets, compliance, etc.

The ability to communicate technically and manage the details of these multifaceted production lines is critical. A strong desire to provide a high level of customer service and develop key customer relationships is needed.

Candidates with previous experience manufacturing pharmaceuticals, who are familiar with FDA 21CFR parts 210 and 211 are preferred. Experience with FDA 21CFR part 820 for medical devices is also applicable.

Job Responsibilities:

  • Create and manage project activities, schedules, and budgets.
  • Identify and manage risk in projects and corresponding activities.
  • Organize and prioritize general action items.
  • Communicate with project members, management, customers, and key stakeholders.
  • Manage customer communications, requests, concerns, and priorities.
  • Execute some project activities including document writing, quality system setup, part inspections, labeling, etc.
  • Hold project meetings, document meeting minutes, and capture and communicate action items.
  • Generate meeting minutes and project records; maintain customer communication throughout the project duration.
  • Assemble necessary documentation sets for internal/external manufacturing.
  • Participate in weekly project status meetings.
  • Monitor and track project costs, staying within budget.
  • Generate ECOs and obtain appropriate approvals and document correspondence.
  • Monitor and track project schedules, staying on schedule.
  • Coordinate shipping and delivery issues, verify internal signoffs, and documentation needed to ship a product.
  • Retrieve manufacturing documentation and update as needed.
  • Archive project notes, data, folders, etc.
  • Generate additional opportunities with existing customers.
  • Facilitate and mediate issues.
  • Work with management to accomplish program goals as needed.
  • Provide continual updates and status to management.
  • Bring customer feedback and/or concerns to management.
  • Participate in existing and future business development and strategic planning.
  • Be willing to accept varying assignments when economic conditions warrant.

Other Responsibilities:

  • Maintain a high personal level of quality.
  • Help assure compliance to regulatory and customer quality requirements.
  • Create and improve company processes and procedures.
  • Participate in team building, training, and departmental communications.
  • Manage corporate risk by evaluating projects and making recommendations.
  • Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.

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