Documentation Manager

AstraZeneca GmbH; Macclesfield; On-site; GBP 60,000 - 85,000; Full time

Job summary

AstraZeneca GmbH is seeking a Documentation Manager on an 18-month fixed-term contract in Macclesfield. You will lead creation and implementation of SOPs and Work Instructions across Manufacturing, Supply Chain and Finance, leveraging AstraZeneca tools and AI capabilities to accelerate delivery while safeguarding GxP and SOx compliance.

Based in Macclesfield, you will manage central documentation repositories, version control, and change management in ECMS, while enabling upskilling and

Qualifications

• Experience with process standardization and ensuring compliance with regulatory guidelines in both SOx and GxP.
• Strong organizational and project coordination skills to drive SOPs across programmes.
• Experience with document management systems ensuring version control and accessibility.
• Background in GxP controlled environments and regulated processes.

Responsibilities

• SOP and WI (Work Instruction) development for Manufacturing and Supply Chain, ensuring audit readiness.
• SOx-compliant SOPs and WI for Finance to enable timely financial close.
• Maintain central repository with version control, metadata and access governance.
• Track documentation status, surface risks, and drive on-time approvals.
• AI-assisted authoring to accelerate drafting of SOPs while preserving quality.
• Verify AI outputs for GxP/SOx compliance before stakeholder review.
• Operate ECMS workflows and manage Document Change Control (DCC).
• Provide guidance and training to promote tool adoption and quality.
• Respond to evolving programme needs with pragmatic solutions.

Skills

Process standardization

Regulatory compliance

GxP and SOx knowledge

Stakeholder management

Project coordination

Documentation governance

Job description

Job Title: 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.

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 solution 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

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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.

Date Posted

14-Aug-2026

Closing Date

23-Aug-2026

Our mission is to build 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.