Director, Clinical Operations Compliance

The Lotus Group LLC; San Francisco (CA); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Relocation assistance

Competitive compensation

Job summary

The Lotus Group LLC in Alameda (Outside San Francisco) seeks a Director/AD, Clinical Operations Compliance to lead GCP/ICH-GCP compliance, risk management, and CAPA governance. You will partner with QA, Clinical Development, and CROs to ensure inspection readiness and robust compliance systems.

This role offers strong ownership, cross-functional influence across study teams, and relocation support for candidates moving to Alameda.

Qualifications

• Requires extensive GCP/ICH-GCP experience embedded in Clinical Operations.
• Proven CAPA ownership with root-cause analysis and closure.
• Ability to influence QA and cross-functional teams.

Responsibilities

• Lead GCP/ICH-GCP compliance and CAPA governance within Clinical Operations.
• Build and improve compliance processes, risk registries, metrics and controls.
• Partner with QA, Clinical Development and CROs to ensure inspection readiness.

Skills

GCP/ICH-GCP compliance

CAPA ownership

Cross-functional influence

Inspection readiness

Education

Bachelor's degree in biotech/pharma

Master's degree in relevant field

PhD in biotech/pharma

Job description

Director/ AD, Clinical Operations Compliance - Outside San Francisco, CA

Join an innovative, growth-stage biotech and have the opportunity to build and strengthen Clinical Operations compliance infrastructure while partnering closely with Clinical Development, Quality, and external CROs.

Why This Role

• Highly visible role with the opportunity to shape compliance strategy, systems, and processes.
• Meaningful ownership and influence across the clinical-development organization.
• Collaborative leadership exposure across Clinical Operations, Quality, and study teams.
• Full relocation support for candidates moving to the Alameda, California area.

What You’ll Do

• Lead GCP/ICH-GCP compliance, trial risk and issue management, and CAPA governance within Clinical Operations.
• Build and improve compliance processes, risk registries, metrics, reporting, and operational controls.
• Partner cross-functionally with QA, Clinical Development, and CROs to drive timely issue resolution and sustained inspection readiness.
• Bring meaningful depth in one or more areas:
• Inspection readiness, BIMO, TMF audit readiness, and health-authority inspection support
• RBQM/RBM, monitoring oversight, and CRO performance management
• GCP training, operational capability building, and quality analytics

What they are Looking For

• Bachelor’s with 13+ years, Master’s with 11+ years, or PhD with 8+ years of relevant biotech/pharma experience (For Director level)
• Direct GCP/ICH-GCP compliance expertise embedded in Clinical Operations—not solely general Clinical Ops or QA experience.
• Strong CAPA ownership experience, including root-cause analysis, action assignment, tracking, effectiveness checks, and closure.
• Proven ability to influence across functions, especially in partnership with QA.