Quality Assurance Expert – GxP Compliance & Patient Impact

Roche Holding AG; Welwyn; On-site; GBP 50,000 - 65,000; Full time

Benefits offered by this job

Flexible working options

18 weeks maternity leave

Gender independent partnership leave

Job summary

Roche UK is seeking a QA professional to oversee operational management of Pharmaceutical Quality Management System processes and support Qualified Persons in fulfilling obligations.

You will translate GxP requirements into Roche policies, collaborate across functions, and drive foundational QMS work to ensure compliance and efficiency. A temporary 12‑month assignment with flexible working options is available.

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
• Desirable experience includes customer complaints processing and management system
• QMS KPI trend analysis and management reporting
• Internal and supplier auditing

Responsibilities

• Oversee operational management of key Pharmaceutical Quality Management System processes and support Qualified Persons.
• Translate external and global GxP requirements into Roche policies and procedures.
• Collaborate cross-functionally to retain Roche UK’s Licence to Operate.
• Lead foundational work to drive efficiency without compromising standards.

Skills

GxP Quality Assurance

CAPA management

Document management

Quality Risk Management

Education

Bachelor Degree in Science

Job description

Roche UK is seeking a QA professional to oversee operational management of Pharmaceutical Quality Management System processes and support Qualified Persons in fulfilling obligations.

You will translate GxP requirements into Roche policies, collaborate across functions, and drive foundational QMS work to ensure compliance and efficiency. A temporary 12‑month assignment with flexible working options is available.