Job Description
Career Opportunity with CK Group
We are recruiting a Senior Process Quality Excellence Specialist to join our client's team in Slough. This is a hybrid role requiring two days of on-site work per week.
Key Responsibilities:
* Support the development of quality and compliance infrastructure, including policies, SOPs, and best practices.
* Collaborate with global quality, patient safety, regulatory affairs, and stakeholders to ensure compliance with ICH GCP, GLP, PV, and local regulations.
* Lead inspection readiness activities across all functions, working closely with relevant teams.
* Provide guidance and training on GCP, GLP, and PV for all phases of clinical drug development.
* Manage Study Specific Training activities within the Learning Management System, creating study training matrices, developing curriculums, and providing support to stakeholders as needed.
Your Background:
* Strong pharmaceutical experience, preferably in global Quality Assurance or Clinical Development.
* Experience writing SOPs.
* Familiarity with Veeva Systems.
* In-depth knowledge of GCP, including hands-on experience in global GCP audits and inspections.
* FDA/EMA inspection readiness experience is essential.