Documentation Governance Lead
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We are partnered with a global biopharmaceutical organisation seeking an experienced Document Governance Lead to support the development of a future-state documentation governance framework across Research and Non-Clinical Development (NCD) activities.
This strategic advisory role will focus on assessing current governance practices, defining a target operating model and developing a three-year roadmap to create a more effective, scalable and digitally enabled documentation governance environment. Working closely with scientific, quality and operational stakeholders, you will help shape governance structures, accountabilities and future-state processes across regulated and non-regulated activities.
Requirements
- Assess current documentation governance processes and organisational maturity.
- Define governance frameworks, stakeholder accountabilities and decision‑making structures.
- Design a future‑state documentation governance operating model.
- Identify simplification, automation and digital transformation opportunities.
- Develop a three‑year strategy and implementation roadmap.
- Facilitate workshops and engage senior stakeholders to drive alignment and adoption.
- Define governance KPIs, success measures and strategic recommendations.
Hard Skills
- Documentation governance or quality governance experience within Life Sciences.
- Experience across Research, Non‑Clinical Development and/or GLP environments.
- Proven experience designing operating models and transformation roadmaps.
- Strong governance design, process optimisation and digital enablement expertise.
- Understanding of regulated documentation and compliance requirements.
Soft Skills
- Strong stakeholder engagement and facilitation skills.
- Ability to influence senior leaders and subject matter experts.
- Excellent communication and executive presentation capabilities.
- Strong analytical and strategic thinking skills.
- Comfortable operating in complex global environments.
Qualifications
- Significant experience in documentation governance, quality systems or strategic consulting within Life Sciences.
- Experience working within pharmaceutical, biotechnology or other regulated environments.
- Proven delivery of governance transformation or operating model initiatives.
- Exposure to Research and Non‑Clinical Development functions preferred.
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