Job Description

Manager/Senior Manager Clinical Quality Assurance

Key Responsibilities

• Establishing robust GCP systems and processes in collaboration with the clinical operations team.
• Assist with Clinical Quality Assurance (CQA) efforts, including Trial Master File (TMF) and site auditing activities.
• Collaborate with clinical teams to ensure adherence to Good Clinical Practice (GCP) standards and internal protocols for clinical trials.
• Play a leadership role in assessing and contributing to clinical program planning and execution, including protocol reviews, informed consent forms (ICFs), corrective and preventive actions (CAPAs), and clinical study reports (CSRs).
• Provide quality oversight for clinical trial partners, such as Clinical Research Organizations (CROs) and contractors, while supporting the identification and onboarding of new third-party vendors as needed.
• Oversee the qualification and ongoing evaluation of GxP suppliers, ensuring significant findings are communicated to Quality Management and relevant stakeholders.
• Review clinical agreements to define roles, responsibilities, and communication protocols for quality-related tasks.
• Conduct internal and external audits, manage the investigation of findings, and oversee corrective/preventive actions, including root cause analysis and effectiveness checks.

Qualifications and Skills

• Bachelor’s or Master’s degree in a scientific field with 7+ years of experience in the pharmaceutical industry or equivalent.
• Comprehensive knowledge of Quality/Compliance standards and GCP, GLP
• Broad expertise in Clinical Quality Assurance practices.
• Proactive, self-driven individual who thrives both independently and within a collaborative team environment.
• Highly organized with exceptional attention to detail and strong communication abilities.
• Experience engaging with global regulatory authorities such as the FDA, EMA, and others.
• Preferred: Experience fostering a culture of GxP compliance in a startup environment.

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