GxP QA Expert & Compliance Strategist

F. Hoffmann-La Roche AG; Welwyn Hatfield; On-site; GBP 65,000 - 90,000; Full time

Job summary

Roche UK is seeking an experienced professional to manage the operational aspects of the Pharmaceutical Quality Management System and to support the Qualified Persons in fulfilling regulatory obligations.

You will translate global GxP standards into Roche policies, drive efficiency while maintaining rigorous compliance, and collaborate with a cross functional team to sustain Roche UK’s Licence to Operate and protect patient safety.

Qualifications

• Working in a GxP Quality Assurance role providing quality and compliance expertise in support of Unplanned and Planned Events, CAPA management, Document management, and Quality Risk Management
• Commercial and/or Clinical Batch Record review for product release
• Health Authority Inspections

Responsibilities

• Operational management of all key Pharmaceutical Quality Management System (QMS) processes and supporting the Qualified Persons
• Translate external and global GxP requirements into Roche policies & procedures
• Adapt to change and identify opportunities while maintaining a laser focus on ensuring compliance; playing a key role in retaining Roche UK’s Licence to Operate
• Utilise skills to work exibly as part of an empowered, self-managed, multi-skilled team to deliver foundational and Squad-prioritised work
• Be authentic and self-accountable, a creative problem solver, a critical thinker and cultivate collaborative relationships across the organisation

Skills

GxP Quality Assurance

CAPA management

Document management

Quality Risk Management

Education

Bachelor Degree in Science

Job description

Roche UK is seeking an experienced professional to manage the operational aspects of the Pharmaceutical Quality Management System and to support the Qualified Persons in fulfilling regulatory obligations.

You will translate global GxP standards into Roche policies, drive efficiency while maintaining rigorous compliance, and collaborate with a cross functional team to sustain Roche UK’s Licence to Operate and protect patient safety.