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Associate Director GCP Quality - Audit & Inspection Management (Contract) 00011

Vertex Pharmaceuticals
  • Remote
  • $90–$100 Per Hour
  • Full-time
2 days ago

Job Description

Job Description:

The Associate Director in the GCP Audit & Inspection Management department is responsible for coordinating and/or conducting audits and inspection management for assigned activities.  This role ensures adherence to GCP regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System.

 

This is a remote role, that requires travel (about once a month)

 

Key Duties & Responsibilities

  • Executes routine and directed audits of GCP vendors, investigator sites and internal processes, as assigned
  • Engages in preparation, support and follow-up activities for inspection readiness
  • Supports due-diligence and business development activities, as requested
  • Participates in collaborative review of impacted SOP/WI
  • Assesses adequacy of audit responses, including corrective and /or preventive actions
  • May participate on process improvement initiatives
  • Provides cross-functional support across Vertex Quality Assurance team
  • Experience working in VEEVA

 

Required Education Level

  • Minimum level of education needed BS or BA degree.
  • Typically requires 8 years of experience or the equivalent combination of education and experience
Pay Range:

AD $90-$100/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

 

Numbers & Facts

Location (
Remote
)
Job TypeFull-time
IndustryBiotechnology/Pharmaceuticals
Salary$90–$100 Per Hour
Company Size5,000 to 9,999 employees
Year Founded1989
Websitehttps://www.vrtx.com/

About Company

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For six years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com

Skills

  • Alliance/Partner Marketingunmatched
  • Auditingunmatched
  • Biotech and Pharmaceuticalunmatched
  • Business Developmentunmatched
  • Corrective Actionunmatched
  • Cross-Functionalunmatched
  • GCP (Good Clinical Practices)unmatched
  • Industry Standardsunmatched
  • Maintain Complianceunmatched
  • Process Improvementunmatched
  • Quality Assuranceunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Regulatory Complianceunmatched
  • Short Messaging Service (SMS)unmatched
  • Standard Operating Procedures (SOP)unmatched
  • Team Playerunmatched
  • Vendor/Supplier Evaluationunmatched
  • Willing to Travelunmatched

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