Vertex Pharmaceuticals

Global GxP Regulatory Intelligence Compendia Manager – Contract

Vertex Pharmaceuticals

contract

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $70 - $75 per hour

About the role

  • Responsible for the ongoing monitoring and management of compendial updates for clinical and commercial programs
  • Ensure compliance with global pharmacopoeia standards and regulatory submissions
  • Maintain alignment with the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and assist in expanding the program to include additional international pharmacopeia such as the Mexican Pharmacopoeia (Mexico Ph), Chinese Pharmacopoeia (ChP), and Japanese Pharmacopoeia (JP)
  • Continuously monitor updates and revisions to EP, USP, Mexico Ph, ChP, and JP and others as programs expand
  • Analyze changes in compendial requirements, work with SMEs to assess impact on company products, processes, regulatory submissions and documentation
  • Provide regular updates to internal stakeholders, including regulatory, quality, and manufacturing teams, on compendial changes and their implications
  • Ensure timely implementation of compendial changes to maintain compliance with regulatory requirements
  • Develop and oversee the execution of Corrective and Preventive Actions (CAPAs) to address any gaps or non-compliance issues identified during compendial reviews
  • Track and ensure completion of all CAPAs before implementation deadlines
  • Assist leading the expansion of the compendial monitoring program to include Mexico Ph, ChP, and JP and others
  • Establish processes and procedures for monitoring and integrating updates from these additional pharmacopoeias
  • Maintain accurate and up-to-date records of compendial changes, assessments, and actions taken
  • Prepare and present detailed reports on compendial updates, compliance status, and CAPA progress to management and relevant teams
  • Collaborate with cross-functional teams, to ensure alignment and effective implementation of compendial changes
  • Act as the primary point of contact for compendial-related inquiries and guidance

Requirements

  • A minimum of a bachelor’s degree in science or related discipline
  • 5-6 years of experience in GMP pharmaceutical/biopharmaceutical industry
  • Understands cGMP concepts and general practices
  • Knowledge and experience in Pharmacopeia, Monographs and Standards and associated revisions
  • Analytical Background
  • Strong attention to detail
  • Project Management and Meeting Facilitation Skills
  • Veeva CAPA Management
Benefits
  • Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
  • Eligible for overtime pay, in accordance with federal and state requirements.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPcGMPPharmacopeiaMonographsStandardsCorrective and Preventive Actions (CAPAs)regulatory submissionscompliance monitoringanalytical skillsproject management
Soft Skills
attention to detailcommunicationcollaborationleadershiporganizational skillsmeeting facilitationstakeholder managementproblem-solvingreportingcross-functional teamwork