GCP Quality consultants

2 weeks ago

Slough, Slough, United Kingdom MSI Pharma Full time £30,000 - £50,000 per year

Two Contract Opportunities – Quality Management System (QMS) Team

12-month contracts (likely extensions) | Inside IR35 | Hybrid: 2 days per week on-site in Slough

A global Biotech organisation is expanding its Quality Management System team and has two openings suited to professionals with
around 3–6 years of experience
. These roles are hands-on and operational, ideal for individuals looking to grow, not suitable for managers or directors, as senior profiles will find the work too administrative and process-heavy.

Both roles support a large QMS covering more than 500 controlled documents across global clinical operations.

1. Quality Assurance Specialist – Audit & Regulatory Intelligence

Focus:
Audit hosting, regulatory monitoring, QMS support.

Responsibilities


• Act as host and point of contact during internal audits


• Liaise with SMEs across clinical operations and quality


• Support audit planning, preparation and follow up


• Monitor regulatory intelligence and identify changes impacting processes


• Contribute to continuous QMS improvements

Requirements


• Approximately 3–6 years of pharma experience in Quality Assurance


• Hands-on involvement in GCP audits (GVP / GLP an advantage)


• Ability to interpret regulatory updates and assess operational impact


• Strong communication and stakeholder coordination skills

2. SOP Writer – Clinical Operations / Data Management

Focus:
SOP writing, process documentation, alignment to GCP standards.

Responsibilities


• Write, revise and improve SOPs and process documents


• Work with clinical operations, GCP and data management SMEs


• Translate complex processes into clear, structured, compliant documentation


• Support alignment to updated global guidance


• Contribute to process harmonisation across the QMS

Requirements


• Approximately 3–6 years of experience in clinical operations or data management


• Strong GCP knowledge and proven SOP writing ability


• Comfortable working with multiple stakeholders to capture process detail


• Excellent organisational and documentation skills

The roles will close soon for CV presentations, so please send suitable CVs ASAP

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