Job Title: GCP Quality Expert
Location: Slough (requires one day per week onsite)
Company: A Global Pharmaceutical Company
Working Hours: Full-Time
Primary Purpose / Regulatory Responsibilities:
The Process Quality Excellence Specialist supports the Head of Process Quality Excellence in developing and maintaining clinical quality systems and procedures. The role focuses on identifying and mitigating quality and compliance risks related to all aspects of clinical studies managed by Global Clinical Sciences and Operations, adhering to Good Clinical Practice, Good Laboratory Practices, and Pharmacovigilance regulations and guidance.
Major Responsibilities:
* Assist the Head of Process Quality Excellence in creating and revising quality and compliance policies, Standard Operating Procedures, processes, and best practices.
* Collaborate with Clinical Development Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure compliance with ICH GCP, PV, and relevant regulations.
* Participate in audit and inspection planning and preparation with Clinical Development Quality and Pharmacovigilance Quality Assurance.
* Represent or ensure representation of Global Clinical Sciences and Operations 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 GCP, GLP, and PV guidance and training to staff across all clinical drug development phases.
* Support Corrective and Preventive Action 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.
* Represent Global Clinical Sciences and Operations in clinical team meetings as needed.
* Perform other duties as assigned.
Experience:
* At least 4 years of pharmaceutical experience in Quality Assurance roles or in GCP audit and inspections.
* Extensive experience with GCP.
* Minimum of 2 years of experience in SOP writing.