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Quality Lead GCP

Quality Lead GCP

LocationGeneva, Switzerland
Business SectorBiotechnology
Contact email
Job ref22192
Published28 days ago

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