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Associate Director Quality Documentation & Training

Company: Opiant Pharmaceuticals
Location: Santa Monica
Posted on: November 18, 2022

Job Description:

As a member of the QA function at Opiant this position will develop and manage the common systems that support Quality Assurance and ensure a compliant environment across GXP regulated activities. -This includes eDMS (electronic Documentation Management Systems), LMS (Learning Management Systems), eQMS (electronic Quality Management Systems).
Job Responsibilities

  • Designs, implements and manages the Document Management and Learning Management Systems at Opiant in support of Quality, Development, Supply Chain and other business partners. - -
  • Manages the lifecycle of controlled documents (Policies, Standard Operating Procedures, Work Instructions, Forms, Records), including development, review, revisions, finalization, periodic review, and retirement.
  • Ensures that controlled documents comply with regulatory and corporate requirements. -
  • Business owner of the Document Management and Learning Management System including eDMS and LMS electronic systems. Ensures functionality and ease of use of these electronic systems to meet evolving needs of the business.
  • Leads the conversion of manual systems to electronic systems for Documentation Management and Training including managing user requirements, system requirements, configuration, system verification/validation and system maintenance. -Coordinates user acceptance testing.
  • Establishes and maintains the Training System including appropriate training curricula, assignment, training records, compliance monitoring and reporting. -
  • Maintains training matrix, tracking role-based training requirements across the company. Assigns training to new and current employees according to the training matrix. Files and tracks training documentation.
  • Serve as subject matter expert for eDMS and LMS as well as configuration and implementation of electronic quality systems.
  • Supports business owner of QMS systems (change management, audits, investigations, deviations, complaint management, supplier management).
  • Gathers business requirements and liaises with software vendor to ensure that business requirements are met by electronic systems. -Ensures that changes or enhancements are implemented efficiently.
  • Leads continuous improvement initiatives and drives simplification of processes
  • Generates quality metrics for management review and continuous improvement initiatives.
    Qualifications & Experience
    • Solid understanding of pharmaceutical and medical device quality assurance principles including global cGMP requirements, 21CFR Part 210 and 211, 21CFR Part 820, and other relevant regulations
    • 5 - 10 years of relevant GMP experience with a pharmaceutical manufacturer or supplier with 5 years of experience in managing of document management and training.
    • Experience leading the selection, implementation, validation and change management of eDMS, eQMS and/or LMS systems.
    • Experience with Veeva Quality Vault (Quality Docs and QMS) preferred.
    • Strong administrative skills including Microsoft Office Suite (Word, Excel, PowerPoint)
    • Experience in interacting with multiple functional groups and working on cross functional teams
    • Ability to travel up to 10%
    • Bachelor's degree in science, business or a related discipline. -


Keywords: Opiant Pharmaceuticals, Santa Monica , Associate Director Quality Documentation & Training, Executive , Santa Monica, California

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