Global Head of Clinical Quality & Compliance

Cytokinetics Incorporated; South San Francisco (CA); Hybrid; USD 222.000 - 260.000; Vollzeit

Benefits dieser Stelle

Stock options and RSUs

Comprehensive health, dental, vision,

Zusammenfassung

Cytokinetics Incorporated in South San Francisco, CA, seeks a Director of Clinical Quality Assurance to lead global quality strategy for clinical development programs and ensure regulatory compliance worldwide. You will establish, maintain, and drive quality programs, SOPs, and QA systems in support of program timelines and patient safety.

You will build and lead the CQA team, oversee audits and inspections, and partner with cross-functional groups to address findings and strengthen processes.

Qualifikationen

• Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline.
• Strong working knowledge of US FDA CFR and EU regulations and ICH-GCP guidance.
• Experience managing and developing staff.
• Able to develop innovative solutions and apply critical thinking.
• Able to organize and prioritize projects and CQA activities based on risk.
• Up to 10% travel may be required.

Aufgaben

• Lead and implement GCP QA strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs.
• Lead and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports.
• Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams.
• Lead and ensure inspection readiness activities for internal and external entities.
• Lead and/or co-host regulatory inspections.
• Lead and oversee CQA’s vendor compliance oversight program and maintenance of GCP Quality Agreements.
• Lead and manage a risk-based audit program and maintain audit metrics.
• Manage and support internal audits of GCP processes, and quality audits of clinical vendors and investigator sites.
• Ensure CQA participation on study teams to provide GCP compliance guidance and oversight to cross-functional stakeholders to ensure adherence to FDA & global regulatory requirements.
• Identify compliance gaps and provide remediation recommendations for continuous improvement.
• Review and approve SOPs, audit reports, quality event records as required.
• Create, maintain, and adhere to department operating budget.

Kenntnisse

GCP compliance

Staff management

Quality systems

Regulatory inspections

Cross-functional collaboration

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

Cytokinetics Incorporated in South San Francisco, CA, seeks a Director of Clinical Quality Assurance to lead global quality strategy for clinical development programs and ensure regulatory compliance worldwide. You will establish, maintain, and drive quality programs, SOPs, and QA systems in support of program timelines and patient safety.

You will build and lead the CQA team, oversee audits and inspections, and partner with cross-functional groups to address findings and strengthen processes.