Senior GCP/GVP Compliance & QA Leader

Meditrial; Minneapolis (MN); On-site; USD 140,000 - 190,000; Full time

Job summary

Meditrial is seeking an experienced quality and regulatory professional to lead GCP and GVP compliance efforts, audit strategy, and QA oversight. The role partners with clinical development, operations, and regulatory affairs to ensure ongoing compliance across all Meditrial projects.

The ideal candidate has 8–10 years in pharma with GCP experience in FDA-regulated settings, plus strong knowledge of ICH and EU regulations, and is able to plan and execute audits, inspections, and training.

Qualifications

• BS/BA degree in scientific discipline or equivalent experience.
• 8–10 years in pharma with at least 5 years in GCP compliance in FDA-regulated settings.
• Experience in large pharma and startups is preferred.
• Knowledge of GCP, GVP, EU, FDA, ICH regulations and best practices.
• Experience planning/conducting GCP/GVP audits and regulatory inspections.
• Experience with Quality Management Systems (documentation, deviations, CAPA).
• Ability to review study-related documentation and reports.
• Strong cross-functional collaboration and communication; travel up to 20%.

Responsibilities

• Formulate GCP compliance strategy for all Meditrial programs.
• Assess GCP/GVP risk areas and implement mitigation measures.
• Develop and prioritize an audit strategy for all programs.
• Plan and lead GVP and GCP audits including sites and labs.
• Report findings with recommendations and verify corrective actions.
• Partner with Clinical Development, Operations, Regulatory affairs on compliance.
• Manage QA reviews of essential clinical study documents.
• Coordinate regulatory inspections and responses to findings.
• Lead GCP/GVP training for relevant personnel.
• Develop and implement standards, policies for GCP/GVP compliance.
• Escalate issues and support internal/external audits as needed.
• Participate in quality/compliance improvement initiatives.
• Provide guidance on GCP/GVP regulations and quality systems.
• Prepare internal QA reports and input for external partners/clients.

Skills

GCP compliance

GVP compliance

Regulatory interpretation

Audit planning

Training leadership

Education

BS/BA in scientific discipline

Job description

Meditrial is seeking an experienced quality and regulatory professional to lead GCP and GVP compliance efforts, audit strategy, and QA oversight. The role partners with clinical development, operations, and regulatory affairs to ensure ongoing compliance across all Meditrial projects.

The ideal candidate has 8–10 years in pharma with GCP experience in FDA-regulated settings, plus strong knowledge of ICH and EU regulations, and is able to plan and execute audits, inspections, and training.