Gxp Inspectorate & Regulatory Engagement Senior Lead

**Vacancy**:
**Vacancy reference**
- VAC-0446
**Department**
- GxP Quality and R&D Compliance
**Location**
- Oslo / London / Washington DC
**Close date**
- 21/06/2026
**Job description**:
**About CEPI**
CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ - its goal to develop safe, effective and accessible vaccines against new threats in just 100 days.
Earlier this year, CEPI launched its CEPI 3.0 Strategy (covering ) which will systematically reduce the likelihood and impact of epidemics and pandemics by driving the 100 Days Mission towards an operational reality.
CEPI is a not-for-profit association under Norwegian Law and has offices in Oslo (HQ), London, and Washington DC.
**-
- 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.
- Create practical, reusable outputs.
- 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: Br