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Change Manager

2 months ago

Conshohocken, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary:


The Change Manager is responsible for managing the change control program, document control program, record management, and training program in compliance with regulatory requirements.

 

Duties & Responsibilities:


  • Manage change control program.
  • Manage document change order system and workflow.
  • Provide technical writing support and review for document change orders.
  • Provide guidance for stakeholders during document collaboration to ensure lean implementation of lean processes and documentation.
  • Collaborate with end users to determine solutions for facilitation of operational tasks.
  • Provide effective communication to various teams to execute successful transitions.
  • Provide support for continuous process improvements.
  • Revise and finalize controlled documents, ensuring consistency and compliance to formatting/template requirements.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Manage and coordinate periodic review of controlled documents.
  • Manage and coordinate new employee onboarding training requirements/assignments.
  • Manage and coordinate recurring employee training requirements/assignments.
  • Serve as administrator for eQMS for addition of users, role configuration, and other administrative functions.
  • Manage record storage and archival in accordance with standard operating procedures.
  • Manage SOP table of contents, master label list, equipment list, signature log, training matrix, and quality event log.
  • Provide quarterly and annual data analytics and reporting for quality events.
  • Initiate, review, and investigate quality events and determine appropriate containment, preventive/corrective actions.
  • Support and/or perform internal and external audits.
  • Develop and implement strategies for adopting changes and ensuring timeliness of projects and initiatives meet their objectives.
  • Maintain working knowledge of regulatory requirements.
  • Perform other related duties as assigned.


Skills & Abilities:

  • Excellent attention to detail.
  • Strong management and leadership skills.
  • Strong Public Speaking skills.
  • Technical writing.
  • Strong analytical thinking.
  • Multi-tasking.
  • Ability to work in fast paced environment.
  • Effective verbal and written communication.
  • Proficient in Microsoft Office.


Education & Experience:


  • Bachelor's degree (life science and/or technical writing preferred)
  • At least 5 years of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) required.