Director, Global GCP QA

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

📋 Description

• Serve as the primary GCP QA subject matter expert and main contact for both early- and late-phase clinical programs, including those in China.

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

• Provide quality oversight and review key clinical and regulatory submission documents such as IND/NDA documents.

• Take ownership of and implement a risk-based GCP audit and compliance strategy across the clinical portfolio.

• Establish GCP quality governance forums and deliver compliance reports to senior leadership.

• Lead the assessment and escalation of significant quality events, serious breaches, systemic trends, and critical and major CAPAs.

• Monitor adverse trends, manage issue trends, and offer recommendations to management.

• Provide strategic oversight of CROs and other essential clinical vendors.

• Manage or mentor GCP QA employees, consultants, and contracted auditors.

• Represent GCP QA in governance committees and major program decision-making.

• Assess and manage vendor-related risks that impact study compliance, data integrity, and participant safety.

• Review clinical trial documentation for data integrity and GCP compliance.

• Develop, maintain, and enhance quality SOPs, manuals, templates, process maps, approval flows, and the GCP QMS.

• Drive continuous improvement initiatives across Global QA processes.

• Collaborate with clinical functions to implement tailored GCP procedures.

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

• Report crucial quality metrics to leadership.

• Develop strategies and lead or conduct routine and for-cause audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs.

• Approve audit findings, reports, root cause analyses, action plans, and audit CAPAs.

• Lead and oversee GCP-related vendor qualifications and oversight.

• Evaluate and mitigate GCP compliance risks.

• Lead sponsor inspection readiness and regulatory inspection activities, including developing inspection strategies, executing front-room/back-room operations, and crafting responses.

• Support global regulatory authority inspections and lead or assist in site and vendor inspection readiness.

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

⛳️ Requirements

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

• An advanced degree is preferred.

• Auditor certifications and/or SQA RQAP credentials are preferred.

• 10+ years of experience in the pharmaceutical or biotechnology sector.

• A minimum of 7+ years in a GCP QA lead auditor role.

• Previous experience in Big Pharma is preferred.

• Proven leadership in supporting regulatory inspections, including those by the FDA, EMA, MHRA, NMPA, and PMDA.

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

• Prior success in designing and implementing QMS systems, including vendor management.

• Working knowledge of EDMS and other document and data management platforms.

• GCP QA experience is required.

• Ability to manage multiple priorities in a fast-paced, evolving environment.

• Exceptional leadership, project management, and communication skills.

• Capability to drive outcomes across matrixed teams and third-party entities.

• Strong strategic thinking and adaptability in a dynamic global environment.

• Travel is required: up to approximately 50% depending on location.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity.

• Ongoing performance-based equity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k match.

• Unlimited PTO.

• Paid holidays, including winter shutdown.

• Remote work option.

• Hybrid model if onsite.

• Equal-opportunity employment.