AI-Powered SOP & GxP Documentation Lead

The Digital Asset Management Consortium, Inc.; Macclesfield; Hybrid; GBP 55,000 - 85,000; Part time

Job summary

AstraZeneca in Macclesfield seeks an experienced professional to drive SOP and Work Instruction development across Manufacturing, Supply Chain and Finance for an 18-month contract.

You will partner with Global SOP Leads, leverage existing AstraZeneca tools and AI capabilities, and ensure GxP and SOx compliance while safeguarding audit readiness and rapid decision-making from shop floor to financial close.

Qualifications

• Experience ensuring processes comply with regulatory guidelines in SOx and GxP.
• Strong organizational and project coordination skills for SOP development across the programme.
• Experience with document management systems and version control for SOPs.
• Ability to interpret AI tool outputs and verify accuracy before stakeholder review.
• Stakeholder management across finance, operations, manufacturing and supply chain.

Responsibilities

• Develop and maintain GxP-compliant SOPs and Work Instructions for Manufacturing and Supply Chain.
• Develop SOx-compliant SOPs for Finance with audit-ready controls.
• Create and manage a central repository with version control and metadata governance.
• Track documentation status and surface risks to enable on-time approvals.
• Use AI tools to accelerate drafting of global SOPs aligned to the programme.
• Verify AI-generated content against regulated processes before review.
• Operate ECMS workflows and coordinate change control processes for content accuracy.
• Provide guidance and training to promote consistent tool adoption and quality.
• Respond to evolving programme needs with pragmatic solutions.

Skills

Regulatory compliance

SOP development

Stakeholder management

Project coordination

Adaptability

AI tool interpretation

Tools

ECMS

AI tooling

Job description

AstraZeneca in Macclesfield seeks an experienced professional to drive SOP and Work Instruction development across Manufacturing, Supply Chain and Finance for an 18-month contract.

You will partner with Global SOP Leads, leverage existing AstraZeneca tools and AI capabilities, and ensure GxP and SOx compliance while safeguarding audit readiness and rapid decision-making from shop floor to financial close.