Vertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases
Global GxP Regulatory Intelligence Compendia Manager (Contract)00000
Location
United States
Posted
79 days ago
Salary
$70 - $75 / hour
Seniority
Lead
No structured requirement data.
Job Description
Global GxP Regulatory Intelligence Compendia Manager (Contract)00000
Vertex Pharmaceuticals
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 By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors
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