R & D QA Lead

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?

Our Client a global leading Healthcare company is looking for an R & D QA Lead

Tasks

* Lead quality oversight activities across R&D, ensuring alignment with internal standards and regulatory requirements.
* Evaluate internal processes and external partners to ensure compliance with GxP and identify areas for improvement.
* Manage investigations, deviations, and corrective actions, ensuring timely resolution and documentation.
* Maintain and improve systems supporting quality performance, risk management, and continuous improvement.
* Support regulatory inspections and partner evaluations, including preparation, coordination, and follow-up.
* Provide expert GxP guidance, contribute to SOP development and training, and collaborate across teams to uphold compliance

Profile

* Evaluate internal processes and third-party partners to ensure compliance with GxP, SOPs, and quality agreements, identifying areas for improvement.
* Support regulatory inspections and partner assessments, including preparation, hosting, and coordination of responses.
* Lead the planning, coordination, and execution of GxP audits across R&D, vendors, and clinical sites, ensuring alignment with internal standards and regulatory expectations.
* Manage audit findings, deviations, and CAPAs, ensuring timely resolution and documentation in line with quality systems.
* Maintain and enhance systems for audit scheduling, performance tracking, and continuous improvement across quality operations.
* Provide expert GxP guidance, contribute to SOP development and training, and collaborate cross-functionally to uphold compliance and quality standards.

Contact
Please contact me on or please call me on +49 30 726211428 for further information.