Associate Director, Global GCP QA

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide independent QA oversight for designated clinical programs.

• Ensure that clinical phases and China clinical programs adhere to relevant health authority regulations and guidelines.

• Evaluate key clinical and regulatory submission documents, such as IND/NDA materials.

• Identify and document vendor-related risks concerning study compliance, data integrity, and participant safety.

• Assess clinical trial documentation to ensure data integrity and GCP compliance.

• Manage quality events and CAPAs, appropriately escalating significant risks.

• Prepare quality metrics and trend analyses for management evaluation.

• Develop, maintain, and enhance quality SOPs, manuals, templates, process maps, and approval workflows.

• Provide quality guidance to clinical functions and implement tailored GCP procedures.

• Assist in continuous improvement initiatives and quality enhancement projects.

• Foster a culture of quality through effective communication, training, and stakeholder engagement.

• Report key quality metrics to leadership.

• Lead audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs.

• Review audit findings and ensure thorough root cause analysis and CAPAs.

• Assist in GCP vendor qualification and oversight.

• Evaluate and mitigate GCP compliance risks.

• Support inspection readiness and manage assigned inspection workstreams.

• Assist during global regulatory authority inspections.

• Stay updated on agency and industry GCP trends, standards, and methodologies.

• Report directly to the Executive Director, Global GCP, QA.

⛳️ Requirements

• A BS/MS or equivalent in a scientific discipline is required.

• A minimum of 8 years of experience in the pharmaceutical or biotechnology field.

• At least 4 years in a GCP QA lead auditor position.

• Previous experience supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA).

• Proficiency in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other international standards.

• Proven success in executing QMS systems, including vendor management and system implementation.

• Familiarity with EDMS and other document and data management systems.

• Highly organized and detail-oriented, with the capability to manage multiple priorities.

• Outstanding project management and communication skills.

• Ability to drive results across matrixed teams and external partners.

• Strong strategic thinking and adaptability in a dynamic, global setting.

• Willingness to travel approximately 50% based on location.

🏝️ Benefits

• Annual performance incentive bonus.

• Equity for new hires.

• Ongoing performance-based equity.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401k matching.

• Unlimited paid time off (PTO).

• Paid holidays, including a winter shutdown.