GxP Inspectorate & Regulatory Engagement Senior Lead

About the role

This role will help CEPI GXP Quality and Compliance team set up and start the initial execution of the CEPI 3.0 Quality activities linked to GxP inspectorates, regulatory authorities, and National Control Laboratories (NCLs).

It supports CEPI 3.0’s aim to enable the 100‑Day Mission by strengthening national regulatory agencies and quality networks by embedding fit‑for‑purpose, risk‑based quality so that speed does not have a detrimental impact on safety, quality, and efficacy.

The role is about listening and understanding what regulatory Inspectorates, authorities and national control labs need to support their GXP related activities and turning this into practical actions that CEPI can fund, catalyse, or advocate for. This builds on what already exists within the ecosystem, avoiding duplication.

It builds directly on the Quality team’s current work (risk‑based quality due diligence, quality agreements, and ongoing monitoring/project support) and uses that baseline to shape the next set of inspectorate/NCL‑focused activities for CEPI 3.0.

This is a fixed term position until December 2027.

Responsibilities

• Engage and listen (stakeholder‑led needs assessment)
• Build and maintain trusted working relationships with GxP inspectorates, NRAs and NCLs across regions.
• Run structured consultations to understand what stakeholders need most to strengthen inspection and local quality control capability in emergencies.
• Map what already exists (avoid duplication)
• Produce a clear landscape view of existing initiatives, networks, tools, and training so CEPI focuses on gaps and does not duplicate what others are already doing.
• Identify where CEPI can add value through funding, catalytic partnerships, or advocacy and where it should not intervene.
• Translate needs into CEPI‑actionable work (fund / catalyse/advocate)
• Turn stakeholder needs into a prioritised set of CEPI‑actionable interventions with clear outcomes, delivery routes, costs (where relevant), and measures of success.
• Make sure proposals align with CEPI's Regulatory & Quality Strategy—strengthening networks, enabling trusted speed, and embedding fit-for-purpose GxP quality—as well as support the goals of CEPI 3.0.
• Link to, and build from, what CEPI Quality already does.
• Use the existing CEPI Quality approach as the operating baseline for new external inspectorate/NCL work.
• Build on existing Quality strategy workstreams that already call out opportunities for engagement with inspectorates and associated bodies.
• Align outputs with the Regulatory & Quality Network objectives and ways of working where relevant.
• Develop a CEPI 3.0 implementation road map.
• Produce a short-term implementation plan and a longer‑term roadmap with milestones, dependencies, governance, and a simple measurement approach that can feed into CEPI 3.0 implementation planning and execution.
• Provide decision‑ready summaries for CEPI leadership on priorities, trade‑offs, and where CEPI should focus effort.
• Make sure that every activity CEPI participates in is sustainable and can be applied to other similar situations or organisations.
• Produce simple artefacts that remain useful after the contract ends (templates, short guidance notes, playbooks).

Education, Experience and Competence

• Degree in a health science or related discipline (advanced degree preferred).
• Professional quality/compliance training or certification is desirable (e.g., lead auditor qualification, inspection readiness experience, or laboratory quality systems training).
• Experience working with regulators, inspectorates and/or NCLs across multiple regions is essential.
• Deep GxP quality and compliance experience: Considerable experience (typically 15+ years) in senior GxP Quality / Compliance roles, with strong knowledge of risk‑based oversight, inspection readiness, and quality systems maturity.
• Proven global regulatory credibility: Broad experience with regulatory authorities and awareness of inspectorate/NCL operations across various regions and maturity levels. Direct experience of working within inspectorates and/or NCLs would be an advantage.
• Turns concepts into practical solutions: Proven ability to translate complex needs into clear programs with defined deliverables, partners, governance, outcomes, and measures. Design practical capacity‑building options (e.g., training/twinning/toolkits) where that is what stakeholders need.
• Pragmatic and stakeholder‑led: Listens well, builds trust, and focuses on what is workable. Uses existing good practice and avoids duplication.
• Clear communicator self‑directed: Produces concise, decision‑ready outputs. Works independently, delivers at pace, and can operate with minimal direction.

Travel and Location Requirements

• This role is based in the UK, Norway or the US (East Coast).
• Willingness and ability to travel internationally as required.

What we can offer you

• The opportunity to work together with leading experts on solutions for global challenges
• Experience from the international effort on developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks
• A diverse and inclusive working environment