Job Description
The Global GxP Regulatory Intelligence Compendia Manager will be responsible for the ongoing monitoring and management of compendial updates for clinical and commercial programs and ensuring compliance with global pharmacopoeia standards and regulatory submissions. This role will focus on maintaining 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) and others
Key Duties & Responsibilities
Compendial Monitoring and Analysis:
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.
Stakeholder Communication and Updates:
Attend relevant forums, conferences, and meetings to stay informed about upcoming changes in pharmacopoeia standards.
Provide regular updates to internal stakeholders, including regulatory, quality, and manufacturing teams, on compendial changes and their implications.
Compliance Management:
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.
Program Expansion:
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.
Documentation and Reporting:
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.
Cross-Functional Collaboration:
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.
Required Education Level and Experience:
A minimum of a bachelor’s degree in science or related discipline is
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 Pay Range
$70-$75/hr
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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Originally posted on Himalayas
