Regulatory Compliance Expert

18 hours ago

Baltimore, Maryland, United States SkyElia Full time

About the Job

The Regulatory Compliance Expert at SkyElia is responsible for ensuring the efficient and compliant operations of our Document Management and Learning Management systems. This role oversees regulatory adherence within GxP guidelines to support business functions effectively.

Key Responsibilities

  • Direct daily operations of Document Control and Training departments to ensure regulatory compliance and operational support.
  • Manage Electronic Document Management System (EDMS) and Learning Management System (LMS) administration locally.
  • Support batch record revision processes and develop engaging GMP training content.
  • Conduct gap analyses to identify training needs and enhance processes.
  • Mentor the Training team on LMS capabilities, training techniques, and process improvements.
  • Drive continuous improvement initiatives for departmental processes.
  • Act as site process owner (SPO) for EDMS, LMS, and associated SOPs, collaborating cross-functionally to mitigate impacts on other departments.
  • Monitor key performance metrics and report findings to management.
  • Stay updated on industry trends and regulatory standards to ensure compliance and best practices.
  • Support client and regulatory audits, and participate in other Quality Systems activities as required.

Qualifications

  • Bachelor's degree in a life sciences or education-related field.
  • Minimum 5 years of experience creating and delivering educational content to adult learners.
  • Preferred: 3+ years in a regulated manufacturing industry, particularly pharmaceuticals or medical devices.
  • Preferred: Previous leadership experience.
  • Experience administering electronic learning and document management systems.
  • Strong understanding of training procedures and techniques (e.g., needs assessment, instructional design, adult learning theory).
  • Proficiency in MS Office suite.
  • Excellent communication skills for diverse audiences and senior management updates.

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