Role Overview
You will lead and shape business change for sterile manufacturing at a UK site. You will work across operations, engineering, quality and supply chain to design, plan and deliver change that improves safety, compliance and supply reliability. This role offers visible career growth and meaningful impact, providing you the opportunity to lead key activities to progress your career.
Responsibilities
- Design, develop and implement the site operational readiness roadmap for the SLT, including milestones, readiness criteria, acceptance thresholds and functional alignment across QA, Operations, Engineering, IT, Supply Chain, Finance, HR and EHS.
- Act as the cross‑functional integrator, coordinating readiness across commissioning, operations, compliance, people, processes, systems, safety, permits, commercial arrangements and organisational change.
- Own the formal change control and governance process, including impact assessments, approvals, governance board updates, go/no‑go decisions, rollback planning and the site change management plan.
- Support commissioning, validation and sterile filling readiness, including IQ/OQ/PQ activities, water runs, media fills, PPQs, utilities, environmental monitoring and equipment readiness.
- Ensure documentation and compliance readiness by updating controlled document registers, SOPs, work instructions, validation master plans, asset registers, emergency plans and regulatory submissions in line with internal and external standards.
- Manage systems and data enablement, including CMMS/EAM, PLC/SCADA integration, MES, ERP, cybersecurity, access controls, data migration, asset hierarchies and system baselines.
- Confirm safe operations, campaign readiness and regulatory compliance, including cleaning/sterilisation procedures, gowning validation, alarm functionality, product mix planning, campaign schedules, changeovers, shift patterns, permits, licences, HAZOP/HAZID and safety submissions.
- Oversee post‑go‑live stabilisation with the SLT, monitoring reliability targets, process KPIs and operational performance while supporting benefits realisation and ongoing enhancement after full operations go live.
Qualifications
- Significant experience working in sterile pharmaceutical manufacturing or aseptic processing environments.
- Proven experience leading change, projects or operational transformations in a regulated site.
- Strong stakeholder management and clear communication with operations, engineering and quality teams.
- Experience defining requirements, supporting testing and delivering readiness for production.
- Demonstrable focus on GMP, compliance and inspection readiness.
- Ability and willingness to work on‑site regularly and collaborate directly with shop floor teams.
Preferred Qualifications
- Degree or vocational qualification in engineering, life sciences, manufacturing or a technical discipline.
- Experience with new product introductions, scale‑up, transfers or capital project delivery.
- Familiarity with continuous improvement methods such as Lean or Six Sigma.
- Knowledge of manufacturing execution systems or electronic batch records.
- Experience coaching frontline leaders and building operational capability.
- Track record of delivering benefits through structured change and measurement.
Working Model
This role is on‑site at Barnard Castle. You should be prepared to spend significant time at the manufacturing site to lead activities and work directly with operational teams.
Equal Opportunity
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
