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Responsibilities Include

• GLP Compliance: Ensure that all Internal, Central and Local Clinical laboratory activities comply with Good Laboratory Practices (GLP) regulations and guidelines. Stay current with regulatory requirements and industry standards related to GLP.
• Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess laboratory processes. Conduct regular reviews to identify areas for improvement and initiate corrective actions as needed.
• Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with GLP standards. Coordinate external inspections and audits from regulatory agencies, ensuring preparedness and timely responses to findings.
• Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs (Standard Operating Procedures), protocols, and reports. Ensure that documentation is accurate, complete, and in compliance with GLP requirements. Ensure all TMF Lab related documentation are filed in a timely and accurate manner.
• Training and Education: Assist in providing training and guidance to laboratory personnel on GLP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures.
• Risk Management: Identify and assess potential risks related to GLP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues.
• Continuous Improvement: Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality.
• Communication: Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements.

Required Qualifications

• Bachelors Degree in a scientific discipline
• Minimum of 2 years hands-on experience in biopharmaceutical operations, technical operations and/or quality operations
• Minimum of 1 year experience with Document Control within a GXP  environment, with specific familiarity with Trial Master File and Quality Management System controlled documents
• Extensive knowledge of GLP, GCP, ICH and FDA biologics regulations
• Demonstrated knowledge of document control systems, preferably electronic systems
• Demonstrated understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
• Cell and gene therapy experience preferred
• Must be highly organized, an effective and proactive communicator verbally and in writing, have disciplined practices of maintaining electronic records in real-time, and be able to work independently.
• Strong team orientation and passion for continuous self-development.

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