Quality Lead GCP

Our client, a leading biopharmaceutical company, operating at the forefront of cutting-edge scientific research and drug development, is seeking a Quality Lead GCP to play a pivotal role in ensuring the quality and compliance of their clinical development processes.

Key Responsibilities:

• Quality Assurance: Oversee and manage the quality assurance processes related to clinical development activities, including clinical trials, to ensure compliance with regulatory standards, SOPs, and guidelines.

• Risk Management: Implement and maintain risk management strategies to identify and mitigate quality and compliance risks throughout the clinical development process.

• Audit and Inspection Readiness: Prepare and lead the organization for audits and inspections, collaborating with cross-functional teams to ensure successful outcomes.

• Training and Development: Provide guidance and training to clinical teams on quality-related matters, fostering a culture of quality and continuous improvement.

• Quality Metrics: Establish, monitor, and report on key quality metrics to drive process improvements and maintain the highest quality standards.

• Regulatory Compliance: Stay up-to-date with relevant regulations, standards, and industry best practices, and ensure that clinical development activities are aligned with these requirements.

• Issue Resolution: Lead investigations into quality issues, non-conformances, and deviations, and implement corrective and preventive actions (CAPAs).

Qualifications:

• Bachelor's or advanced degree in a life science or related field.
• 6 years of experience in clinical quality assurance within the pharmaceutical, biotech, or CRO industry.
• Strong understanding of GCP (Good Clinical Practice) regulations and guidelines.
• Proven experience in managing and leading quality assurance activities in clinical development.
• Exceptional communication and leadership skills, with the ability to collaborate effectively with cross-functional teams.

Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.

?: +41 (0) 44 5514 407

?: c.kelly@panda-int.com