Director, GCP Quality Assurance

Scorpion Therapeutics; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Equity

Bonus

Life/disability/EAP

Tuition assistance

Paid time off

Parental leave

Sick time

Job summary

Scorpion Therapeutics in San Diego, CA seeks a Director, GCP Quality Assurance to lead global GCP audit programs across the clinical development portfolio, ensuring compliance with FDA, ICH, EU and other requirements.

You will oversee internal and external audits of CSPs, CROs, investigator sites, and vendors; develop quality systems, SOPs, and quality agreements; support inspections and readiness; and provide expert guidance to cross-functional partners.

Qualifications

• Bachelor’s in Life Sciences or equivalent education/experience.
• 10+ years in pharmaceutical/biotech/regulatory industry.
• 5+ years in GCP Quality Assurance, compliance, and auditing.
• Lead Auditor experience for internal/external GCP audits.
• Strong knowledge of ICH-GCP and FDA/EU GCP regulations.
• Audit experience covering CROs, investigator sites, and providers.
• Experience supporting regulatory inspections/inspection readiness.

Responsibilities

• Plan, schedule, conduct, and manage GCP audits of CSPs, CROs, sites, and vendors.
• Prepare and review audit reports; document observations and corrective actions.
• Develop and maintain GCP Quality Agreements with CROs and study partners.
• Maintain GCP audit metrics and quality reporting for mgmt reviews.
• Develop and maintain SOPs supporting GCP auditing and compliance.
• Manage internal GCP audit program from planning to effectiveness assessments.
• Support mock and regulatory inspections and responses.
• Provide GCP compliance guidance to cross-functional stakeholders.

Skills

Lead Auditor

GCP QA

Auditing

Regulatory knowledge

Cross-functional

Education

Bachelor's in Life Sciences

Equivalent education/experience

Tools

eCOA

CSV

Data management

Job description

Position Summary

The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across the clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. Provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and serves as a GCP compliance subject matter expert.

Primary Responsibilities

• Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors
• Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
• Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
• Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews and continuous improvement
• Develop/review/maintain SOPs and quality documents supporting GCP auditing and compliance
• Manage internal GCP audit program (planning, execution, follow-up, and effectiveness assessments)
• Support mock and regulatory inspections and responses for GCP studies/quality systems
• Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other global requirements
• Recommend and implement improvements to GCP quality systems, processes, and procedures

Education & Experience (Required)

• Bachelor’s in Life Sciences or related field (or equivalent education/experience)
• 10+ years in pharmaceutical/biotech/regulated industry
• 5+ years in GCP Quality Assurance, compliance, and auditing
• Lead Auditor experience for internal/external GCP audits
• Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations
• Audit experience covering CROs, investigator sites, and GCP service providers
• Experience supporting regulatory inspections/inspection readiness

Preferred Qualifications

• SQA/ASQ/Lead Auditor certification
• Experience conducting global audits across US/EU/UK/Japan and other regions
• Experience with eCOA, CSV, and data management

Benefits (as stated)

• Medical, dental, vision; 401(k) match 1:1 up to 5%; equity; bonus; life/disability/EAP; tuition assistance; paid time off; paid parental leave; sick time.

Physical/Other

• Ability to travel overnight independently and work after hours if required.
• Occasionally lift/move up to 15 pounds.