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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director GCP Quality - Audit & Inspection Management (Contract) based in the United States.
We are seeking an experienced GCP Quality professional to coordinate and conduct audits while overseeing inspection management activities across clinical research operations. In this role, you will help ensure compliance with Good Clinical Practice regulations, industry standards, and internal quality requirements. You will conduct audits of clinical vendors, investigator sites, and internal processes while supporting inspection readiness and follow-up activities. Working closely with Quality Assurance and cross-functional teams, you will assess audit responses, corrective actions, and opportunities for continuous improvement. This remote contract opportunity offers a senior-level scope with regular travel, approximately once per month. Your expertise will help maintain robust quality systems and support the integrity of clinical research activities.
As a key contributor to GCP Quality Assurance, you will oversee audit execution, inspection readiness, and compliance activities while collaborating with internal stakeholders and external partners. Your responsibilities will include:
Conduct GCP audits: Execute routine and targeted audits of clinical research vendors, investigator sites, and internal processes in accordance with applicable regulations and quality standards.
Manage inspection readiness: Coordinate and support inspection preparation, readiness activities, inspection support, and post-inspection follow-up.
Evaluate audit responses: Review and assess the adequacy of audit responses, including proposed corrective and preventive actions (CAPAs), to ensure appropriate resolution of identified findings.
Support due diligence: Contribute to due-diligence assessments and business development activities when required.
Review quality documentation: Participate in collaborative reviews and updates of relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Drive continuous improvement: Contribute to process improvement initiatives that strengthen quality systems and compliance practices.
Collaborate across teams: Provide cross-functional support to the broader Quality Assurance organization and work with relevant stakeholders to maintain consistent quality standards.
Use quality management systems: Apply experience with Veeva to support audit, inspection, and quality-related activities.
The ideal candidate brings substantial experience in GCP quality, clinical research auditing, and inspection management, along with the ability to assess compliance risks and work effectively across teams. Required qualifications include:
Bachelor's degree (BS or BA) in a relevant discipline.
Typically 8 years of relevant professional experience, or an equivalent combination of education and experience.
Experience conducting and coordinating GCP audits, including audits of clinical vendors, investigator sites, and internal processes.
Knowledge of Good Clinical Practice regulations, industry standards, and quality management requirements.
Experience supporting inspection readiness, inspection activities, and follow-up processes.
Ability to evaluate audit responses and corrective and preventive action plans.
Experience working with Veeva.
Strong analytical, organizational, and communication skills, with the ability to collaborate across multiple functions.
Willingness to travel approximately once per month.
Hourly compensation: $90–$100 per hour.
Work arrangement: Remote position within the United States.
Travel: Approximately one trip per month.
Overtime eligibility: Eligible for overtime pay in accordance with applicable federal and state requirements.
Contract opportunity: Temporary assignment through a third-party staffing partner.
Employment benefits: Compensation, medical coverage, fringe benefits, and other employment terms will be provided by the staffing partner upon offer.