Summary: The Process Quality Excellence Specialist role involves supporting the development of quality and compliance infrastructure within a global pharmaceutical company. The position requires collaboration with various stakeholders to ensure adherence to international regulations and inspection readiness. The role also includes managing training activities and participating in audits and inspections. This is a hybrid position based in Slough, initially on a 12-month contract.

Key Responsibilities:

• Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
• Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
• Participate in Audit and Inspection planning with Global Quality.
• Manage Study Specific Training activities within the Learning Management System (LMS), including creating and maintaining study training matrices, developing relevant curriculums and courses, and providing support to GCSO stakeholders.
• Attend improvement initiatives to enhance quality and compliance processes and effectiveness in collaboration with stakeholders.

Key Skills:

• Strong pharmaceutical experience, preferably in a global Quality Assurance or Clinical Development setting.
• In-depth experience of GCP, including hands-on experience in global GCP audits and/or inspections.
• FDA/EMA inspection readiness experience is essential.

Salary (Rate): £28.16

City: Slough

Country: UK

Working Arrangements: hybrid

IR35 Status: inside IR35

Seniority Level: undetermined

Industry: Other