SOP & GxP Documentation Lead — 18‑Month Contract

AstraZeneca; Macclesfield; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

AstraZeneca is seeking a Documentation Manager for an 18-month fixed-term contract based in Macclesfield. The role focuses on creating and implementing SOPs and Work Instructions across Manufacturing, Supply Chain and Finance, using ECMS, AI tools, and robust governance to ensure GxP and SOx compliance.

You will lead documentation projects, manage central repositories, track status, and provide upskilling to promote consistent documentation practices in a dynamic, regulated environment.

Qualifications

• Experience ensuring processes comply with regulatory guidelines (SOx & GxP).
• Strong project coordination to develop and implement SOPs across programme.
• Experience with document management systems for version control and accessibility.
• Background in GxP controlled environments and compliance.

Responsibilities

• SOP and WI Development (GxP): draft, review, revise SOPs/Work Instructions for Manufacturing and Supply Chain with audit readiness.
• SOx SOP/WI Development: support SOx-compliant SOPs for Finance and timely close.
• Central Repository Management: establish and maintain a central documentation repository with version control and access governance.
• Documentation Status Tracking: build mechanisms to track progress and surface risks early for approvals.
• AI-Assisted Authoring: use AI tools to accelerate drafting of global SOPs aligned to the programme plan.
• Manual Compliance Verification: verify AI-generated content against regulated processes.
• ECMS Ownership: operate controlled document workflows and manage Change Control.
• Enablement and Upskilling: provide guidance and training for tool adoption.
• Ad Hoc Support: respond to evolving programme needs while maintaining quality.

Skills

SOx Compliance

GxP Compliance

Regulatory Knowledge

Project Coordination

Stakeholder Management

Document Management

AI Tool Interpretation

Tools

ECMS

Job description

AstraZeneca is seeking a Documentation Manager for an 18-month fixed-term contract based in Macclesfield. The role focuses on creating and implementing SOPs and Work Instructions across Manufacturing, Supply Chain and Finance, using ECMS, AI tools, and robust governance to ensure GxP and SOx compliance.

You will lead documentation projects, manage central repositories, track status, and provide upskilling to promote consistent documentation practices in a dynamic, regulated environment.