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AstraZeneca

Documentation Manager

Macclesfield
Posted about 17 hours ago
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Documentation Manager - 18 months Fixed Term Contract

Location: Macclesfield

Introduction to Role

Are you ready to turn complex, cross-border processes into clear, compliant ways of working at global scale? This 18-month contract will place you at the heart of a company-wide ERP transformation, partnering with Global SOP Leads to build and deploy the standards that help our people deliver with confidence.

Based in Macclesfield, you will drive the creation and implementation of SOPs and Work Instructions across Manufacturing, Supply Chain, and Finance, accelerating delivery through established AstraZeneca tools and new AI capabilities while safeguarding GxP and SOx compliance. Do you see yourself shaping a single, trusted set of operating documents that supports faster, safer decisions from shop floor to financial close?

Accountabilities

  • SOP and WI (Work Instruction) Development (GxP):
    • Contribute to the creation, review, and revision of GxP-compliant SOPs and Work Instructions for Manufacturing and Supply Chain, ensuring clarity, accuracy, and audit readiness.
  • Finance SOP and WI Development (SOx):
    • Support the development and maintenance of SOx-compliant SOPs and Work Instructions for Finance, enabling consistent controls and timely financial close.
  • Central Repository Management:
    • Establish and maintain a central documentation repository with robust version control, metadata, and access governance to manage the full document lifecycle.
  • Documentation Status Tracking:
    • Build and run mechanisms to track document progress and readiness, surfacing risks early and driving on-time approvals.
  • AI-Assisted Authoring:
    • Use AI tools to accelerate drafting of global SOPs aligned to the programme’s strategic plan, increasing speed without compromising quality.
  • Manual Compliance Verification:
    • Verify AI-generated content against regulated processes, confirming GxP/SOx compliance and alignment to standards before stakeholder review.
  • ECMS Ownership:
    • Operate controlled document workflows in ECMS, own Document Change Control (DCC), coordinate reviews and approvals, and ensure process adherence and metadata accuracy.
  • Enablement and Upskilling:
    • Provide guidance and occasional training to promote consistent tool adoption, documentation quality, and efficient ways of working.
  • Ad Hoc Support:
    • Respond to evolving programme needs with pragmatic solutions that maintain delivery pace and quality.

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Essential Skills/Experience

  • Experience with process standardization and ensuring that processes comply with regulatory guidelines, regulatory requirements, and industry best practices in both SOx and GxP.
  • Strong organizational and project coordination skills to assist in the timely development and implementation of SOPs across the programme.
  • Experience with document management systems and tools to track and maintain SOPs, ensuring version control, accessibility, and GxP compliance.
  • Background understanding of GxP controlled environments and the importance of compliance, document accuracy, and adherence to established regulated processes.
  • Proven track record of stakeholder management skills including examples of building effective cross-functional relations (e.g., finance, operation, manufacturing, supply chain).
  • Experience in delivering solutions to challenges to maintain delivery against timelines and quality standards.
  • Ability to manage competing demands, re-prioritise work at short notice, and adapt to changing plans while maintaining quality and delivery timelines.
  • Ability to interpret AI tool outputs, identify inaccuracies or gaps, and ensure document content is accurate, complete, and ready before stakeholder review.

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Desirable Skills/Experience

  • Ability to collaborate effectively with multiple teams, including manufacturing, supply chain, IT, Finance, and procurement, ensuring alignment and coordination across departments.
  • Supports documentation delivery across both project and BAU activity, adapting to shifting priorities and ensuring continuity of service.

Why AstraZeneca

Here, scientific ambition meets practical delivery. You will help codify how a global biopharma operates—bringing standardized processes, common data, and real-time insight to thousands of colleagues so they can move from bench to patient with greater speed and certainty. We put unexpected teams together to solve real problems, use cutting-edge technology to modernize end-to-end operations, and value kindness alongside ambition so you can do bold work with the right support. Your contribution will ripple from the factory floor and finance close to the medicines that change patients’ lives.

What is Next

We are looking forward to receiving your application not later than 23rd August.

Date Posted

14-Aug-2026

Closing Date

23-Aug-2026

Our Mission

We are committed to building an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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Skills

Process Standardization
Regulatory Compliance
GxP
SOx
Document Management Systems
Version Control
Project Coordination
Stakeholder Management
AI Tool Utilization
Document Change Control
Technical Writing
Audit Readiness
Cross-functional Collaboration
Metadata Governance
Process Improvement

Location

Macclesfield, England, United Kingdom

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