SOP & GxP Documentation Lead (18-Month Contract)

AstraZeneca; Macclesfield; On-site; GBP 45,000 - 65,000; Full time

Job summary

AstraZeneca Macclesfield is seeking a Documentation Manager for an 18-month fixed-term contract to lead SOP and Work Instruction development across Manufacturing, Supply Chain and Finance, ensuring GxP and SOx compliance. You will implement AI-assisted authoring and manage ECMS workflows to enable faster, safer decisions.

A strong focus on quality, audit readiness, and stakeholder collaboration is essential.

Qualifications

• Experience ensuring GxP/SOx compliance in regulated environments.
• Strong experience with SOP/WI development across multiple functions.
• Ability to interpret AI tool outputs and ensure accuracy before review.

Responsibilities

• SOP and WI (GxP) development for Manufacturing and Supply Chain.
• SOx SOP/WI development for Finance and financial close.
• Central documentation repository management with version control.

Skills

Regulatory compliance

SOP development

GxP standards

SOx controls

Document management

Project coordination

AI-assisted drafting

Stakeholder management

Education

Bachelor's degree in Life Sciences

Tools

ECMS

SOX compliance tools

Job description

AstraZeneca Macclesfield is seeking a Documentation Manager for an 18-month fixed-term contract to lead SOP and Work Instruction development across Manufacturing, Supply Chain and Finance, ensuring GxP and SOx compliance. You will implement AI-assisted authoring and manage ECMS workflows to enable faster, safer decisions.

A strong focus on quality, audit readiness, and stakeholder collaboration is essential.