About the Role
We are seeking an experienced Clinical Process Excellence Lead to join our team at Planet Pharma. This individual will play a critical role in ensuring the highest standards of quality and compliance throughout the clinical drug development process.
* This lead will work closely with the Head of Process Quality Excellence to develop and maintain clinical quality systems and procedures.
* Responsibilities include assisting in the creation and revision of quality and compliance policies, SOPs, processes, and best practices.
Main Responsibilities:
* Lead the development and implementation of quality and compliance initiatives.
* Collaborate with Clinical Development Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure regulatory compliance.
* Participate in audit and inspection planning and preparation with Clinical Development Quality and Pharmacovigilance Quality Assurance.
* Represent GCSO accurately during audits/inspections by internal and external parties.
* Contribute to improvement initiatives aimed at enhancing quality and compliance processes.
* Stay updated on regulatory trends and share key insights within the organization.
* Provide guidance and training to GCSO staff across all clinical drug development phases.
* Support CAPA activities, including tracking and monitoring for timely closure.
* Identify and mitigate compliance risks, resolve potential issues, and escalate critical risks to the Clinical Quality Management Lead.