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Project Manager II

Salary undisclosed

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Role: Project Manager

Location: Murrysville, PA (Onsite)

Experience Required: 8+ Years

Job Summary

We are seeking an experienced Project Manager to lead the transfer of our manufacturing line, ensuring compliance with regulatory standards in the medical products industry. This role requires a proactive leader who can navigate complex projects while maintaining a strong focus on quality, safety, and efficiency.

Key Responsibilities
  • Project Planning: Develop and implement a comprehensive project plan for the manufacturing line transfer, ensuring adherence to all regulatory and compliance requirements.
  • Cross-Functional Coordination: Collaborate with engineering, quality control, regulatory affairs, and operations teams to facilitate a smooth and compliant transfer process.
  • Timeline and Resource Management: Oversee project timelines, budgets, and resource allocation to ensure the successful transfer of the manufacturing line while prioritizing quality outcomes.
  • Risk Management: Identify potential risks and challenges during the transfer process, and develop strategies to mitigate disruptions to ongoing operations.
  • Compliance Oversight: Ensure all transfer activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant industry standards.
  • Logistics Coordination: Work with supply chain and logistics teams to manage the transportation of equipment, materials, and products during the transfer.
  • Stakeholder Communication: Provide regular updates to stakeholders and leadership on the progress of the manufacturing line transfer, addressing any concerns or challenges that may arise.
  • Validation and Testing: Conduct comprehensive validation and testing of the transferred manufacturing line to ensure it meets all necessary quality standards for medical products.
  • Documentation: Ensure all transfer activities are thoroughly documented, and that the new manufacturing line setup complies with all applicable standards and regulations.
  • Team Leadership: Lead and support the project team to foster effective communication, collaboration, and successful execution of transfer activities.
  • Skills: Strong communication, leadership, and problem-solving abilities, with demonstrated expertise in project management and medical product manufacturing.

Qualifications
  • Bachelor's degree in Management, Operations, Engineering, or a closely related field.
  • PMP certification is a plus.
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