Quality Engineer

Quality Control / Quality Assurance Engineer (GxP, Biopharma, and Life Sciences) - Cell and Gene Therapy

We are seeking an experienced Quality Control / Quality Assurance Engineer to join our team and ensure that our products meet regulatory requirements and exceed customer expectations. The successful candidate will have extensive knowledge of GxP, biopharma, and life sciences regulations and will provide technical support to ensure the quality and safety of our cell and gene therapies.

Key Responsibilities:

• Develop and implement quality control and assurance strategies for cell and gene therapy products in compliance with GxP, biopharma, and life sciences regulations
• Perform risk assessments and develop risk management plans for product quality and safety
• Review and approve batch records, specifications, test methods, and other technical documents to ensure compliance with regulatory requirements
• Provide technical support to manufacturing, analytical, and quality control teams to ensure that products meet quality standards
• Conduct internal and external audits of facilities, systems, and processes to ensure compliance with regulatory requirements
• Investigate and resolve quality issues and non-conformances and implement corrective and preventive actions
• Prepare and submit regulatory filings and reports as required by regulatory authorities
• Collaborate with cross-functional teams to develop and implement quality improvement initiatives
• Keep up-to-date with regulatory requirements and industry best practices and communicate changes and updates to the relevant stakeholders

Qualifications and Requirements:

• Bachelor's or Master's degree in a scientific discipline, preferably in biology, biochemistry, or biotechnology
• At least 5 years of experience in quality control or quality assurance in a GxP regulated environment, preferably in biopharma or cell and gene therapy
• Strong knowledge of GxP, biopharma, and life sciences regulations, particularly FDA and EMA regulations, and experience in regulatory compliance and filings
• Experience in analytical methods development and validation • Strong communication and interpersonal skills, and ability to collaborate effectively with cross-functional teams
• Experience in conducting internal and external audits
• Experience in root cause analysis and implementation of corrective and preventive actions
• Ability to work independently and proactively, and manage multiple tasks simultaneously
• Attention to detail and strong problem-solving skills

If you are passionate about quality and safety, and want to work in a fast-paced, dynamic environment with a team of talented and committed professionals, we encourage you to apply for this exciting opportunity.