We are looking for an experienced Clinical QA Contractor to join our client on a 6-12 month contract with high potential of conversion to permanent after the initial contract term. This will be full time, 40 hours a week with 2-3 days required on site.
The company are focussed in Oncolgy, with a strong pipeline, with big ambitions and year on year growth! Interested in joining their mission to find new alternatives for some of the most aggresive cancers? Read on to find out how you can help...
This role will focus on supporting clinical trial compliance, ensuring alignment with internal procedures, regulatory requirements (FDA, EU, ICH, and local regulations), and best practices in the industry.
Key Responsibilities:
- Collaborate with clinical departments (e.g., Clinical Operations, Clinical Development) to provide guidance on GCP compliance.
- Participate in clinical study teams to facilitate risk-based quality management and encourage a culture of transparency and excellence.
- Conduct quality assessments of clinical trial documents, ensuring adherence to regulatory guidelines and focusing on risk mitigation.
- Work with internal teams and external auditors to assist in planning, preparing, conducting, and closing GCP audits.
- Oversee quality aspects of clinical trial activities and perform regular assessments of clinical vendors.
- Support activities for regulatory inspection readiness.
- Address quality issues related to GCP and clinical trial execution, including investigation, root cause analysis, and CAPA management.
- Escalate significant findings to the QA leadership as necessary.
- Contribute to various GCP or GXP-related activities as assigned.
- Assist in audits and regulatory inspections of the company, service providers, and investigator sites.
Requirements:
- Bachelor's degree in alife sciences or related discipline
- At least 12 years of experience in GCP quality assurance within the pharmaceutical or biotechnology sector.
- Extensive experience in audit management, regulatory inspections, CAPA processes, and overall quality management systems.
- Strong understanding of ICH GCP guidelines and global regulatory requirements (FDA, EMA) pertaining to drug development.
- Excellent verbal and written communication skills.
- Ability to build strong working relationships with cross-functional teams and external partners.
- Skilled in problem-solving and managing complex issues with attention to detail.
- Proficiency in Microsoft Office and related software (e.g., Word, Outlook, Excel, PowerPoint, Visio).
Please note - No C2C
