[Hiring] Associate Director GCP Quality - Audit & Inspection Management @Vertex Pharmaceuticals

Role 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).

• 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.

Qualifications

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

Requirements

• 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.

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No C2C or Third-Party Vendors.