Director, Clinical Quality Assurance

Scorpion Therapeutics; California (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

Cytokinetics is seeking a Lead for the Clinical Quality Assurance (CQA) department to ensure GCP compliance and inspection readiness. Based in South San Francisco, CA, you will develop and execute GCP QA strategies, lead audits, manage inspections, oversee quality systems, and drive continuous improvement across clinical development programs.

The role requires 12+ years in GCP disciplines, a life sciences degree, and strong US/EU regulatory knowledge, with up to 10% travel.

Qualifications

• Bachelor's degree in life sciences required.
• 12+ years experience in GCP-related disciplines.
• Strong knowledge of US and EU regulations including ICH-GCP.
• Experience managing teams and conducting audits.

Responsibilities

• Develop and execute GCP QA strategies.
• Lead internal and external audits.
• Manage inspection activities.
• Oversee quality systems.
• Support continuous improvement across clinical development programs.
• Manage and develop QA staff.
• Implement performance metrics.
• Ensure regulatory compliance in US and EU contexts.

Skills

GCP knowledge

Audit leadership

Team leadership

Regulatory compliance

Quality systems

Education

Bachelor's in life sciences

Job description

Role:

Lead the Clinical Quality Assurance (CQA) department for Cytokinetics, focusing on GCP compliance and inspection readiness.

Responsibilities:

• develop and execute GCP QA strategies
• lead internal and external audits
• manage inspection activities
• oversee quality systems
• support continuous improvement across clinical development programs
• manage and develop QA staff
• implement performance metrics
• ensure regulatory compliance in US and European contexts

Qualifications:

• Bachelor's in life sciences
• 12+ years in GCP-related disciplines
• strong knowledge of US and EU regulations including ICH-GCP
• experience managing teams and conducting audits

High-Value:

• clinical quality assurance
• GCP/GVP/GMP inspection leadership
• risk-based auditing
• regulatory compliance in US/EU
• experience supporting clinical development in cardiovascular or muscle biology areas

Work Setup:

• based in South San Francisco, CA
• up to 10% travel