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.
Job Tags
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